Our client is a prominent organization dedicated to advancing innovative healthcare solutions. With a strong emphasis on regulatory excellence, they are committed to delivering safe and effective medicinal products globally. The Regulatory Affairs Manager will be responsible for managing the regulatory lifecycle of OTC and Consumer products, from initial development through post-market activities, ensuring full compliance with relevant regulations and standards. This position will require close cooperation with cross-functional teams and regular engagement with regulatory authorities. Key Responsibilities: Compile, review, and submit regulatory documents throughout the product lifecycle, including eCTD files (Modules 1 and 3), initial marketing authorizations, variations, notifications, and renewals. Prepare and respond to inquiries from regulatory agencies. Track and manage timelines for license variations, notifications, and renewal approvals. Ensure compliance with regulatory requirements, guidelines, and standards. Update regulatory documentation to ensure ongoing company compliance. Participate in discussions with regulatory agencies and manufacturers. Provide regulatory guidance to manufacturers to ensure adherence to relevant standards. Oversee compliance of artwork and packaging, including the preparation of Summary of Product Characteristics and Patient Information Leaflets according to Quality Review Documents (QRD). Work closely with R&D, Quality, and Marketing teams to meet regulatory requirements across the product lifecycle. Offer regulatory advice to project teams during product design, development, evaluation, or marketing. Stay informed on current national and international legislation and guidelines. Organize and maintain electronic archives for regulatory affairs documentation. Candidate Requirements: Scientific background with a master's degree in pharmaceutics, healthcare, life sciences, or a related discipline. At least 5 years of experience in regulatory affairs within the pharmaceutical industry, preferably with international exposure. Solid understanding of pharmaceutical development and process validation. Demonstrated experience in maintaining regulatory compliance documentation (e.G., technical files, regulatory dossiers). Experience in interactions with regulatory authorities and agencies. Strong planning and time management abilities. Thorough knowledge of relevant European guidelines and legislation. Proficient in English (both written and spoken). Personality traits: determined, persuasive, assertive, and communicative. #J-18808-Ljbffr
