Biotech CMC RA Manager

Job description

Join the professional team of Gedeon Richter Plc., a leading pharmaceutical company in Hungary and the region! As a supportive company, we offer to our colleagues a broad spectrum of health and well-being services as well as proprietary facilities for leisure time and recreation. Richter employees and their families may enjoy our holiday resorts, sports fields, swimming pools, kindergartens, doctor's offices, and we also provide comprehensive health screening every two years. Gedeon Richter is looking for a committed and experienced professional for the position Biotech CMC RA Manager Responsibilities You will be accountable for authoring, review and delivery of the CMC dossiers with high quality standards and within portfolio defined timelines Develop/implement effective CMC regulatory strategies for clinical trial material and all marketing authorization procedure submissions worldwide You will be accountable for CMC-related Life-Cycle Management and post-approval activities (variations) of marketed products and for delivery of submission packages with high quality standards and within portfolio defined timelines Provide guidance for regulatory CMC aspects of finished products and development products in multiple projects; you identify regulatory drawbacks Develop, author and/or review documents to ensure that all submissions conform to health authority guidelines/expectations Drive internal and external (Health Authorities) regulatory CMC discussions and interactions to facilitate review and approval of submissions for all CMC aspects of the dossier Provide interpretation of regulatory guidance documents, regulations and directives – advise Manufacturing, Quality, Process/Analytical Development and Comparability units regarding their applicability and impact on internal programs Providing high quality, proactive, strategic, effective and efficient healthcare compliance advice. Manage the development and discussion of the company strategy if needed Solve complex and high-responsibility tasks independently Make independent professional decisions in case of high complexity tasks Identify and proactively mitigate roadblocks Identify, solve and communicate regulatory CMC risk and key mitigations Participate as an (pro-)active member of multi-disciplinary teams, ensuring appropriate and effective communication to define content for regulatory submissions Your profile At least a MSc in life science or relevant scientific field (e.g. Biochemistry, Biology, Chemistry, Chemical Engineering, Pharmaceutics with focus on protein chemistry) 2+ years of experience in Industry or at Health Authority in regulatory CMC of biotechnological products (Registration, Post-approval procedures, Clinical trial applications, Scientific Advices) Good understanding of current regulations in EU, USA and ROW for (investigational) medicinal products Good understanding of current GMP for biotechnological medicinal products Robust understanding of biologics / recombinant molecules and biosimilars (synthetic peptides is a plus) Experience with document management systems and CTD publishing software. Knowledge of industry change control procedures/systems is a plus. Positive, open-minded, curious, and eager to learn every day. Growth mindset, a “can-do” attitude Very good written and oral English communication skills Other information The position is fixed-term (maternity leave) We offer Great opportunity for professional development in an innovation driven department Great reputation at a well established pharmaceutical firm Stability and a trustworthy workplace Work in multidisciplinary teams Training and development opportunities Medical services and life insurance Various sport and health opportunities Excellent work life balance The Richter community is looking forward to your application.