One of our leading pharma clients in Amsterdam has a job opening for a Senior Manager Regulatory Affairs.
As an Senior Manager Regulatory Affairs – CMC for innovative biologics including cell and gene therapy products, you are responsible , for development of the CMC Regulatory strategy and pathways, and managing development of the Regulatory Affairs plan for the different investigational products. Develop and recommend company policy and position on Regulatory Affairs issues assuring that they are aligned with Health Authority requirements. In addition, you will ensure that regulatory documents are of high quality and submitted timely.
- Represent the Regulatory Affairs department/be the Regulatory Affairs Lead in multi-disciplinary project team meetings.
- Participate in the design of the company’s product strategy.
- Liaise with Regulatory Authorities (FDA, EMA, Health Canada and/or local competent authorities) on clinical programs, ODDs, marketing authorizations and product compliance issues and ensure that the company’s activities comply with the regulatory requirements.
- Be responsible for managing the compilation and submissions of all regulatory filings within established timeframe and schedule by coordinating filing activities between departments and local/regional regulatory groups.
- Ensure that the company’s activities comply with US, European and other regulatory requirements together with the local/regional regulatory experts.
- Provides CMC regulatory input to change management processes
- Keep track of the regulatory activities and commitments in a centralized place
- Support other departments to ensure regulatory requirements are met
- Maintain current knowledge of relevant regulatory requirements for drugs, ATMP’s and biological products in US, Europe and Canada.
- University degree (PhD or MSc) in a life science discipline.
- 5+ years experience in regulated pharma environments (research, development, manufacture or analytics)
- At least 3 years in a regulatory CMC or quality department or as technical/scientific reviewer at competent authorities.
- Strong background in either of the fields of gene or cell therapy applications, genome editing, mRNA vaccination, CAR-T, NK-cell technologies.
- Familiar with FDA, EMA, Health Canada and/or competent authorities in relation to regulations on Biologics/ATMPs/Regenerative Medicine.
- Regulatory Affairs knowledge on CMC development.
ORGANISATION AND OFFER
People from all over the world, together as one team, contribute to improving the lives of patients every day. They offer an exciting position in an innovative, dynamic and inspiring environment where you'll receive a competitive remuneration package, autonomy and the opportunity to make your own mark within the company. They create an environment where ideas are shared, experiences are impactful, and talent is developed. Because of their inclusive and family-like environment, you will always have the feeling of belonging & appreciation.
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme? Check this LINK
For more information please contact Ralph Looijen on +31 (0)20 20 44 502