Senior Manager / Associate Director Global Regulatory Affairs CMC Biologics m/v Geel Belgium,
This position will support and manage the regulatory activities at company and CMO manufacturing sites associated with the Chemistry, Manufacturing and Controls (CMC) for licensed and clinical MAbs products. It concerns a gobal role, with focus and presence on the manufacturing site in Geel (BE)
- Represent GRA CMC Biologics in Site quality review meetings and on project teams while working closely with Manufacturing, Quality and Technical Support groups and site Management
- Contribute to Site Change Controls assessment
- Contribute to Technology Transfer team activities
- Contribute to Deviation assessment and Investigations support
- Review and sign-off for site quality and technical documents (SOPs, protocols, batch records, ..)
- Provide pre-approval or routine inspection support at sites
- Provide Regulatory strategy for technical documentation (project plans, change control, deviations, CAPA)
- Be responsible for assuring that regulatory strategy is aligned with Health Authority requirements from a global perspective
- Interact with Global RA colleague's world-wide, participating in the development of global regulatory strategies and CMC programs
- Possibly supervise and coach a team of regulatory professionals and be responsible for their development.
- Support contact with US FDA and EMA on specific CMC topics
- Manage or directly contribute to the CMC writing, preparation, review and approval of regulatory CMC dossiers for submission
- Assure that submission dossiers meet appropriate quality standards
- Assure that technical and regulatory CMC issues are appropriately resolved
- Minimum of a Bachelor's Degree; advanced degree (Masters, PhD) in a science/health field (eg, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent, is desirable.
- Technical pharmaceutical CMC experience (laboratory, biomanufacturing, etc.) is desirable. Typically, an additional 1-5 years of direct Regulatory CMC experience is preferred. However more than 5 years may be applicable for certain associates within an individual contributor career path.
- Experience working for a Regulatory Health Authority is helpful but not essential.
- Must have some knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues.
- Should demonstrate initiative, some independent thinking, anticipatory foresight, and be able to communicate effectively to internal and external audiences.
- Fluency (oral and written) in English language is strongly recommended
- A challenging position in a mutlinational growing environment with state of the art equipment.
- A place in a driven, fun organisation where the patient is nr. 1 priority
- An attractive salary and several extralegal benefits (health care and pension plan, meal vouchers, etc)
- Immediately fixed contract
- The opportunity to travel, see other sites, build up a network