Regulatory Affairs Associate Consultant Plm Jobs

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

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. Job Title ANALYST REGULATORY AFFAIRS Consultant Job Summary Ensures proper submission and approvals for market licenses including new registrations, changes and timely renewals, and establishment registrations, organizing and balancing a multitude of projects simultaneously. Scope Major Roles and Responsibilities Elaborate regulatory strategy and execute submission of changes, new registrations and renewals in timely manner with some guidance. Execute activities to obtain or update establishment registration licenses. Execute post-approval activities such as preparation of communications to stakeholders, labels and Instructions for Use and system updates. Request and follow-up of documentation to prepare registration dossiers. Supports regional team on product submissions schedules, prioritization, and pipeline management. Support internal and external audits with documentation requests. Interacts with other stakeholders, government agencies in a professional, decisive, & articulate manner. Act as a point of contact for stakeholders to support business plans and regulatory needs. Review labels compliance in internal system. · Support projects as representative of the subject/country. · Elaborate procedures of the ar

re 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. Regulatory Affairs Jr. Specialist Consultant / Especialista Jr. de Asuntos Regulatorios Location / Ubicación: Ciudad de México, México Position Summary / Resumen del puesto: Support the preparation, review and follow-up of regulatory submissions for medical devices, ensuring compliance with applicable regulations before health authorities such as COFEPRIS, enabling timely approvals and maintenance of product registrations. Apoyar en la preparación, revisión y seguimiento de trámites regulatorios para dispositivos médicos, asegurando el cumplimiento de la normativa aplicable ante la autoridad sanitaria COFEPRIS, facilitando la obtención y mantenimiento de los registros sanitarios. Key responsabilities / Responsabilidades principales: Prepare and compile regulatory documentation for COFEPRIS submissions (registrations, renewals, changes). Follow up on submissions with regulatory authority (COFEPRIS). Support interpretation of local and international regulations. Support coordination of requests and activities with cross-functional teams. Maintain updated regulatory files and databases. Preparar y compilar documentación regulatoria para sometimientos ante COFEPRIS (registros, renovaciones, modificaciones). Dar seguimiento a los trámites ante autoridad regulatoria (COFEPRIS). Apoyar en la interpretaci

Job Description Job Title: Senior Executive / Specialist - Case Processing E mployment Type: Contract Location: Brazil (Remote) A bout ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities: Experience in Intake/Triage, Data Entry, Quality Review, Case Finalization/Distribution of cases received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience in raising follow-up queries, as necessary, with appropriate documentation in the safety database. Experience in ARGUS database. Experience in rare disease portfolio. Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements. Training and mentoring skill (ICSR, Safety database etc.). Candidate Profile: Bachelor’s or Master’s in Pharmacy / Life Sciences or above and in alignment with project / business team requirements. Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream. Must have hands on experience with MS office applications (Outlook, Excel, Word, Power Point

Associate Regulatory Affairs Specialist — Bogota, Colombia. Apply via Workday.

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Job Description Essential Duties and Responsibilities The Associate Marketing Manager, Global Marketing – Access is responsible for driving global marketing strategy and execution across the full product lifecycle for the Access portfolio. This role serves as the primary commercial representative for new product development (NPD), sustaining project organization (SPO) initiatives, and in‑market optimization, working cross‑functionally with R&D, Regulatory Affairs, Medical, Quality, Supply Chain, Finance, and regional marketing teams. This role is an individual contributor with significant influ

Dear Candidate We have immediate vacancies for the post of Chemist, Microbiologist, Production, Quality Assurance, Quality Control, Regulatory Affairs, R & D, Pharma, Research Associate, Lab Asst. Qualification : BSc / MSc Freshers and Experienced Salary : 4 Lakhs Per Annum to 9 LPA Contact Mr Vasanth Managing Director 7353549756 / 8722187029 Karnataka Information Solution No.6, Basement Floor, ASVNV Bhavan, Opp State Bank Of India, K.G Road, Majestic, Bangalore - 09 PH : 080 - 22260106.

About the Team OpenAI's Legal team plays a crucial role in furthering OpenAI's mission by tackling innovative, fundamental legal issues in AI. If you're passionate about doing significant and unique work as a technology lawyer, this team is for you. The team comprises legal professionals from diverse fields, including technology, privacy, IP, corporate, cybersecurity, employment, tax, regulatory, and litigation. About the Role We’re growing our world-class Legal team and seek an experienced counsel to lead our global hardware IP portfolio initiatives, including patent, trademark and other intellectual property matters related to our business. This role is highly cross-functional across OpenAI, including work across our Legal, Communications, Global Affairs, Product, Research and Executive teams. This role is based in San Francisco, CA. We use a hybrid work model of 3 days in the office per week and offer relocation assistance to new employees. In this role, you will: Own global hardware IP initiatives, including setting and executing on the strategic direction and management of our hardware IP portfolio. Create scalable processes internally and externally with outside counsel to build, maintain and protect our hardware IP portfolio. Developing and maintaining internal hardware IP policies and programs. Engaging externally on hardware IP policy issues. Advising on strategic hardware IP deals. Advising on hardware IP issues, ranging from patent, trademark, trade secret to open source. Developing and building internal AI expertise, processes and tools to facilitate legal team work. Experience advising on complex technology transactions and inbound technology licensing. You might thrive in this role if you: Have at least 10+ years of combined hardware IP experience at innovative technology companies and law firms. Have a JD and license or qualification to practice in CA. Have a strong sense of ownership, are inquisitive and enthusiastic about technology, enjoy being con

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: 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’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. 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. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging cathe

Atlas HXM is the global workforce platform built on compliance. We help companies determine how to engage each member of their workforce and then execute with accountability built in — direct Employer of Record (EOR), Agent of Record (AOR), payroll, and compliance capabilities backed by a decade of practitioner-led expertise. Recognized as a category Leader by NelsonHall and Everest Group, Atlas HXM builds Human Experience Management into everything we do, guided by our "For People, by People" principle. The future of work is borderless, and so are we. Our people are located around the globe — in the U.S., the UK, India, Colombia, China, and beyond. Diversity and belonging are not just values; they are who we are. We are also committed to making a positive impact. Through our Environment, Social, and Governance (ESG) impact initiative, we are addressing our environmental footprint and promoting social responsibility. Our impact program is central to our vision and culture, focusing on employee wellness, diversity, charitable work, and ethical corporate governance. Head of Global Regulatory Affairs and Entity Corporate Governance (12-month fixed-term maternity cover) The Head of Global Regulatory Affairs and Entity Corporate Governance will lead the company’s regulatory strategy, ensuring compliance with all relevant regulations. This senior role focuses on managing regulatory affairs for the organization and providing strategic guidance on governance matters to support our corporate entities globally. The Head of Global Regulatory Affairs and Entity Corporate Governance will work closely with legal, risk & compliance, and operational teams to implement a regulatory framework that meets both local and international requirements while fostering best practices in corporate governance. This is a 12-month fixed-term contract for an individual contributor. Key Responsibilities 1. Regulatory Strategy Develop and execute a comprehensive regulatory strategy that al

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: 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’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. 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 Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing produc

Regulatory Affairs Specialist — 4 Locations. Apply via Workday.

Regulatory Affairs Intelligence Specialist — United States - Minnesota - St. Paul. Apply via Workday.

Deputy General Manager - Regulatory for AGEL Source: Adani Group | Job ID: 49743

Regulatory Affairs Manager – Heart Failure (on-site) — United States - California - Pleasanton. Apply via Workday.