Regulatory Affairs Cmc Associate Jobs

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: The Associate Director, Global Regulatory Affairs will be responsible for day-to-day regulatory activities of early/late phase investigational products, leading the writing and submission of IND/CTA/amendments and future marketing application submissions, providing guidance to the team on regulatory filings and responses, and providing critical regulatory intelligence and guidance back to the team. The Associate Director will work on cross-functional teams, partnering with key internal/external team members including Regulatory CMC and Regulatory Operations to ensure the scientific data and submissions fulfills agency expectations in a compliant manner. Responsibilities: Serve as the regulatory representative on core teams, developing and planning regulatory submission strategies, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities Oversee the compilation, review, and submission of regulatory applications and submissions to agencies, ensuring accuracy, completeness, and timeliness Monitor the regulatory environment and communicate developments to various stakeholders within the company (clinical, regulatory, senior leadership, etc) Stay updated on global regulatory guidance and regulations, communicating key updates to senior leadership and project team management to ensure compli

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Regulatory Affairs CMC Consultant for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. About the Role We are seeking an experienced Regulatory CMC professional to support Client’s pharmaceutical and self-care portfolio. This role will provide regulatory CMC expertise across new product development, lifecycle management, post-approval changes, and global regulatory submissions . The successful candidate will partner closely with Regulatory Affairs, R&D, Supply Chain, Quality, and other cross-functional teams to develop and implement effective CMC regulatory strategies. Key Responsibilities Lead or support Regulatory CMC strategy for new product development and lifecycle management programs. Provide CMC regulatory guidance for pharmaceutical and self-care products across global markets. Develop, review, and maintain CTD Module 2.3 and Module 3 documentation. Prepare and review CMC content for regulatory submissions, including new applications, variations, and post-approval changes. Assess proposed CMC changes for regulatory impact, compliance, risks, and submission requirements. Provide regulatory guidance on manufacturing, formulation, analytical methods, specifications, stability, packaging, and related CMC topics. Act as the CMC representative on cross-functional product development and lifecycle management teams. Partner with R&D, Manufacturing, Quality, Supply Chain, and Regul

Responsibilities: Manage the preparation and submission of new product registrations, post approval submission, and follow-up closely on queries and through approval Responsible for reviewing and writing CMC modules 2 and 3 Exposure to EU and CIS region in regulatory filings Herbal product development background Manage and coordinate product life cycle management Ensure regulatory compliance with local regulatory requirements Foster and maintain professional relationships with the health authorities Provide regulatory support including timely registration of new product and line extensions to support new product launches and tender applications when necessary Maintain regulatory work processes and tracking tools that improve performance levels and transparency Exposure in writing of Product Quality Review Promote regulatory intelligence in both local and regional initiatives Develop regulatory strategies, prepare regulatory applications, and support maintenance activities within relevant therapy areas Execution of regulatory strategies (local and regional) that are in line with the business plan Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met Ensure adherence to timelines and quality set parameters R eview of formulation, generation of ingredient list, and claims per set standards Compilation and review of labeling components per SOP Deliverables: CMC modules 2 and 3 Management of the preparation and submission of new product registrations, post approval submissions, and follow-up on queries through approval Review of CMC modules Execution of regulatory strategies (local and regional) that are in line with the business plan Compilation of PQR as per SOP – Summary report of variations submitted as per the specified period. Review of formulation, generation of ingredient list, and claims per set standards Compilation and review of labeling components per SOP Experien

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA, Foster City, CA or El Segundo, CA office beginning in January 2027. While this role will be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite. Key Responsibilities Regulatory Strategy and Program Leadership Lead or support integrated global CMC regulatory strategies for both T-cell drug product and LVV, with clear differentiation between early-stage, pivotal/late-stage, registration, and post-approval expectations. <sp

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description The Manager, Global Regulatory CMC will support Kite’s autologous CAR T cell therapy portfolio, providing regulatory CMC leadership for global clinical development and commercial expansion across multiple regions. This role is responsible for CMC regulatory submissions, lifecycle management, and change management in alignment with global regulatory strategy and business objectives. The individual will serve as a key Regulatory CMC representative on cross functional program teams, partnering closely with Technical Operations, Quality, Process Development, Analytical, Manufacturing, and Global Regulatory Affairs. Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA, Foster City, CA or El Segundo, CA office beginning in January 2027. While this role will be base

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description This is an office based/hybrid position. The Manager, Regulatory Affairs CMC is located in El Segundo, CA, Thousand Oaks, CA, Foster City, CA or Parsippany, NJ. Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA, El Segundo, CA, Foster City CA or Parsippany, NJ office beginning in January 2027. While this role has the option to be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite. Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations), including submissions supporting lentiviral vector (LVV) manufacturing, testing, control strategy, and l

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description This is an office based/hybrid position. The Manager, Regulatory Affairs CMC is located in El Segundo, CA, Thousand Oaks, CA, Foster City, CA or Parsippany, NJ. Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA, El Segundo, CA, Foster City CA or Parsippany, NJ office beginning in January 2027. While this role has the option to be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite. Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations), including submissions supporting lentiviral vector (LVV) manufacturing, testing, control strategy, and lifecycl

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: Vice President of CMC Regulatory will lead all aspects of CMC Regulatory. Reporting into the Senior Vice President of Regulatory, you will provide strategic and operational leadership to ensure the effectiveness of the CMC Regulatory team and the integrated CMC team. With their lead candidate planning to initiate Phase 3, the candidate must plan for and have extensive drug development expertise. The company offers innovative science, competitive compensation, and a patient-focused company culture. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month). Responsibilities: Develop and own the global CMC regulatory strategy for the portfolio, and provide input to corporate and program strategy, including Phase 3 readiness, marketing application planning, and launch Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities, including leading CMC-focused meetings (e.g., End-of-Phase 2, pre-submission, Scientific Advice) and responses to information requests Responsible for ensuring the appropriate execution of CMC regulatory strategy Set standards and expectations for submission quality and cross-functional delivery and hold the team accountable for results Build, lead, and develop a high-performing CMC Regulatory team as the company sc

About Tr1X Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance in autoimmune and inflammatory diseases. Leveraging the unique biology of Tr1 cells, the company is advancing a pipeline of off-the-shelf allogeneic and in vivo CAR-Tr1 therapies designed to deliver targeted immunoregulation and address diseases driven by immune dysfunction, including transplant-related complications. Founded by pioneers in the discovery of Tr1 cells, Tr1X, Inc. is focused on developing durable, potentially curative therapies for conditions with high unmet need. For more information, visit www.tr1x.bio. Position Summary The Director, Medical and Regulatory Writing reports to the Vice President, Head of Regulatory Affairs and provides strategic planning, development, review, and delivery of high-quality medical, clinical, and regulatory documentation supporting Tr1X clinical programs. The role is responsible for establishing and executing medical writing strategies across clinical development programs, ensuring the timely preparation of scientifically accurate, regulatory-compliant documentation. The Director drives document quality and operational excellence and collaborates with senior leaders across Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Translational Medicine, CMC/Technical Operations, and other functions. The position plays a critical role in supporting regulatory milestones and submissions throughout the product lifecycle, while ensuring alignment with applicable regulatory requirements, scientific standards, and corporate objectives. Key Responsibilities Partner with Regulatory to develop and implement the medical writing strategy in alignment with corporate objectives, clinical development plans, regulatory strategies, and program goals. Author (writes & edits) high-quality documents across all program areas as needed such as clinical study protocols, protocol ame

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: Kailera Therapeutics is a late clinical-stage biotechnology company advancing a diversified pipeline of GLP-1-based therapies for people living with obesity, including ribupatide (an injectable, once-weekly GLP-1/GIP dual agonist currently in global Phase 3 trials), an oral formulation of ribupatide, KAI-7535 (an oral GLP-1 receptor agonist), and KAI-4729 (an injectable GLP-1/GIP/glucagon tri-agonist). The Vice President, CMC Drug & Device Development will own Chemistry, Manufacturing, and Controls (CMC) strategy and execution across this portfolio — spanning drug substance, drug product, device and combination product development, and oral solid dose formulation. This is a highly cross-functional, build-and-run leadership role responsible for advancing Kailera's pipeline from late-stage clinical development through regulatory filing and toward commercial launch readiness. Reporting to the Chief Technology Officer, the VP will lead a growing CMC organization and serve as a key member of the Technical Operations leadership team, partnering closely with Regulatory Affairs, Quality, Clinical Development, and Commercial to ensure a robust, compliant, and scalable supply chain for Kailera's medicines. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month). Respo

JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: Career development with an international company where you can grow the career you dream of. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position is based at our Mississauga office within the Medical division and requires on‑site presence four days per week, with the option to work remotely one day. What You’ll Do Prepare robust regulatory applications to achieve departmental and organizational objectives. Create, review and approve engineering changes. Act as a team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed. Review and evaluate communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards to various local affiliates. Maintain pertinent Canadian medical device regulations to ensure submission requirements are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and

Responsibilities: Supports UK, Ireland, Malta, Sweden, Finland, Norway, and Denmark products across the product portfolio. Supports the team with regulatory strategies (local and regional) that are in line with the business plan Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate. For example, but not limited to: Prepares and compiles regulatory submissions, response to questions, renewals, post submission/approval activities (including relevant updates to external websites such as emc, medicines.ie and In-Demand) Supports ad hoc projects (e.g., compliance reviews, audit preparation etc.) Signs off on packaging material, leaflets, and SmPCs (as appropriate) Supports the compilation of the Northern Cluster team metrics for the EMEA biannual metrics report Supports all regulatory activities in Malta Ensures regulatory compliance within the department to include: The maintenance of global, regional, and local databases Adherence to processes, SOPs, work instructions, and job aids Updates to relevant local and global databases to track current product information Supports team with Calls for Information (CFI) and assist in any Pharmacovigilance- related activities within the Northern Cluster, which may include: Receiving and monitoring responses to CFIs through liaison with UK and EAME colleagues Ensuring responses are submitted in a timely manner and that they are in line with standard procedures and metrics established by the VP Regulatory Affairs in European Regulatory Provide support and responses to ad hoc requests received from UK PV group or Global Reg Med Mailbox Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate. Ensures regulatory compliance within the department Experience/Qualifications: Bachelor's/Master's degree in Life Science/Pharma Minimum of 5 ~ 8 years of relevant work experience worki

POSITION SUMMARY Title: Regulatory Advisor - FDA Pharma & IVDR Natera is a clinical genetic testing company specializing in non-invasive, cell-free DNA (cfDNA) and liquid biopsy testing . The Regulatory Advisor plays a key role in developing and driving regulatory strategy on behalf of the regulatory affairs (RA) team, specifically focusing on FDA Pharma and IVDR initiatives. At Natera, we remember there is a person behind every sample . This role combines strong technical knowledge and an understanding of regulatory requirements (US FDA, CAP/CLIA/NYS, EU, or Japan) to support the approval and registration of products that proactively inform disease management . You will represent the RA team to internal and external stakeholders through written and verbal communication. This role maintains product registrations, change assessments, post-market surveillance reports, and records of communication with regulatory authorities. You will support the overall effectiveness of the RA team through contributions to staff development, process improvements, and maintaining a deep understanding of current regulatory requirements in the evolving diagnostics landscape. PRIMARY RESPONSIBILITIES Represent the regulatory function on designated cross-functional teams. Conduct business interactions with customers and regulatory authorities regarding regulatory pathways, performance claims, supporting data, and labeling in the context of submissions or registrations. Build and execute bold, practical regulatory strategies for complex regulatory affairs programs, with a heavy emphasis on FDA Pharma, IVDR, and In Vitro Diagnostic (IVD) systems. Advocate for the least burdensome approaches to product clearance and approval while strictly interpreting and adhering to regulatory requirements. Coordinate and prepare regulatory submissions with minimal supervision, including EU/IVD/IVDR Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications,

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Responsibilities · Accountable for aligned markets for required regulatory in-scope ancillaries and samples · Understand aligned markets regulatory ancillary requirements · Manage aligned markets ancillary and samples requests are completed per agreed timelines in support of planned regulatory submissions · Manage in a matrix environment with effective communication across multiple functions · Escalate to Client and Contractor point of contact when timelines may not be reached. · Maintain Clients systems and process throughout processing of request to ensure real time reflection of request is visible to all users. Minimum requirements 3+ years Regulatory experience Demonstrated ability to support international product approval Demonstrates ability to work within a demanding environment with a strong focus on quality and timelines. Proven technical aptitude and ability to quickly learn and apply new software, regulations and quality standards. Can demonstrate leadership and team skills. Advanced Microsoft Office Suite skills. Highly efficient communicator. Acts decisively and seizes ac

J ob Title: Director, Regulatory Affairs, Pharmaceuticals Employment Type: Permanent Location: 300 Welsh Road, Building 5, Suite 201, Horsham, PA 19044, USA A bout ClinChoice ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Director, Regulatory Affairs (Hybrid) on a permanent basis. DUTIES & RESPONSIBILITIES : As the Director of Regulatory Affairs for Pharmaceuticals & Biotech, you will have the opportunity to formulate and implement strategies to support multiple leading clients for various regulatory activities. The ideal candidate is a go-getter, exceptional communicator, and strategic thinker who thrives in a fast-paced environment with multiple demands and quickly becomes a trusted partner to their peers and clients alike. Key Responsibilities: · Provide strategic and tactical leadership of the regulatory affairs function in North America, in close collaboration with cross functional teams. · Lead client interactions and act as Subject Matter Expert on Regulatory projects for the biopharma clients. · Ensure compliance with all appropriate government regulations, industry guidelines, and best practices. · In collaboration with regulatory colleagues globally, devise and implement global regulatory strategy and provide leadership oversight for clients’ projects. · Manage, oversee and/or prepare regulatory documents and submissions in accordance with clients’ requirements. · Act as SME with deep knowledge of HA regulations for all aspects of biopharmaceutical regulations. · Collab