REGULATORY AFFAIRS Analyst Consultant

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

Job Description Job Title: Medical Reviewer Employment Type: Contract Location: Brazil Experience – 2 to 5 Years About 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 centres 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: Awareness and understanding of relevant GVP modules. Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance. Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc. Support triage of cases and determine seriousness and relatedness across products as assigned. Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative. Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas. Involve in process improvement

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 an Area/Local Safety Officer Consultant for 12 months Contract with possibility of extension to join one of our clients. The Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners . 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. Main Job Tasks and Responsibilities: Safety and PV System Management Perform the quality check of the PV cases and ensure that the English translation has been properly performed. Keep up to date a local tracker of the individual safety reports. Be the subject matter expert at local level on the case management activities. Closely follow the respect of the regulatory timelines of the submission of the safety reports to the local health authorities and communicate any potential delay to the appropriate teams. Establish and maintain local indicators on the compliance of the safety reports submission. Oversee the training of the local employees and the business partners. Maintain KPI and present them during regular team meetings. Perform regulatory monitoring for impact on vigilance activities and responsibilities. Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders). Maintain overs

Your wellbeing, our mission. Join a company shaping a healthier world. GET TO KNOW US At Wellhub we're revolutionizing workplace wellness. Our platform connects employees worldwide to the best partners for fitness, mindfulness, therapy, nutrition, and sleep—all in one simple subscription. Headquartered in NYC with team members in Europe, North America and South America, we’re on a mission to make every company a wellness company. We believe work should be fulfilling, inspiring, and balanced. Here, you’ll find a team that values wellbeing, collaboration, and different perspectives, where passion and creativity push boundaries to create real impact. Your contributions will help shape a healthier, more balanced world for you and millions of people globally. Join us in redefining the future of wellbeing! THE OPPORTUNITY We are hiring a Staff Product Manager to help build our Occupational Health bet inside New Ventures based in Brazil . This is a Remote – Brazil position, meaning you can work from anywhere within the country. Please note that this role is only open to candidates in Brazil. Occupational health is one of the largest, most regulated, and most stubbornly analog corners of corporate wellbeing. In Brazil alone, it is a multi-billion real market: every company is legally required to run occupational exams, manage regulatory compliance (NR-01 and the new psychosocial-risk mandate, eSocial reporting), and look after the health of its workforce. Yet the industry still runs on paper, manual scheduling, fragmented clinics, and reports nobody reads. We intend to rebuild it, at AI speed. You will partner directly with the Founder/GM of the Occupational Health bet as the product lead of a small, single-threaded squad. This is a 0-to-1 build: the thesis is set, the market is chosen, but the product, the workflow, and the operating model are still being invented. You report to the VP Product, New Ventures, and you'll work daily with the Founder/G

Your wellbeing, our mission. Join a company shaping a healthier world. GET TO KNOW US At Wellhub we're revolutionizing workplace wellness. Our platform connects employees worldwide to the best partners for fitness, mindfulness, therapy, nutrition, and sleep—all in one simple subscription. Headquartered in NYC with team members in Europe, North America and South America, we’re on a mission to make every company a wellness company. We believe work should be fulfilling, inspiring, and balanced. Here, you’ll find a team that values wellbeing, collaboration, and different perspectives, where passion and creativity push boundaries to create real impact. Your contributions will help shape a healthier, more balanced world for you and millions of people globally. Join us in redefining the future of wellbeing! THE OPPORTUNITY We are hiring a Legal Manager to our Legal team in São Paulo, Brazil ! The Legal team at Wellhub acts as a strategic partner to enable sustainable business growth while safeguarding the company across global markets. In this role you will serve as a legal strategist for Brazil, driving complex B2B negotiations, managing regulatory and litigation matters, and directly advising leadership. This is an exciting opportunity for an experienced legal expert to take full ownership of high-impact commercial agreements and key legal initiatives within a fast-paced, global technology environment. YOUR IMPACT Act as a strategic legal advisor to business teams in Brazil, leading the drafting, analysis, and negotiation of vendor agreements and B2B client contracts, including Public Sector deals. Address key legal and commercial topics, including intellectual property, commercial terms, and data privacy arising from contracts, client negotiations, and strategic initiatives. Serve as a trusted advisor to senior leadership, proactively anticipating legal risks, implementing preventive measures, and offering strategic solutions to support business expansion.

Every day, tens of millions of people come to Roblox to explore, create, play, learn, and connect with friends in 3D immersive digital experiences– all created by our global community of developers and creators. At Roblox, we’re building the tools and platform that empower our community to bring any experience that they can imagine to life. Our vision is to reimagine the way people come together, from anywhere in the world, and on any device. We’re on a mission to connect a billion people with optimism and civility, and looking for amazing talent to help us get there. A career at Roblox means you’ll be working to shape the future of human interaction, solving unique technical challenges at scale, and helping to create safer, more civil shared experiences for everyone. We are hiring a Senior Product Policy Manager with expertise in regional compliance and localized policy contextualization for LATAM. You will join a growing team that works across the Americas, Europe, Middle East, Africa, Oceania, India and Asia-Pacific, and is responsible for aligning Roblox's product with global and regional norms by adapting our policies to evolving international and regional regulations and expectations. A member of the Product Policy team, you will have a global impact on our policy and safety strategy. You will collaborate internally with our product, engineering, business, legal, public policy, marketing, communications, and operations teams to help drive the business forward on a foundation of safety & civility. You will: Collaborate with our Legal and Public Policy teams to articulate Roblox's Safety vision, policies and standards to LATAM regulators Adapt Roblox’s global policies to regional markets and work with our Moderation Operations team to ensure they are effectively enforced Analyze the landscape across industry and regulatory activity to proactively anticipate and address risks to Roblox and our users Work directly with our product