Regulatory Affairs Manage
Regulatory Affairs Manage
Rotterdam
Netherlands
Permanent
BioInformatics/BioStatistics
1
About the Role
As our Regulatory Affairs Manager, you will play a crucial role in guiding our innovative therapies through the complex regulatory landscape. You’ll be responsible for developing and implementing global regulatory strategies to support our product pipeline from early development through commercialization.
Key Responsibilities
- Develop and execute regulatory strategies for multiple development programs
- Prepare and manage regulatory submissions (INDs, NDAs, BLAs, MAAs) to FDA, EMA, and other health authorities
- Serve as primary liaison with regulatory agencies, including organizing and participating in meetings
- Provide regulatory guidance to cross-functional teams throughout product development
- Ensure compliance with evolving regulations and guidelines
- Manage and mentor junior regulatory affairs staff
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field
- 7+ years of progressive regulatory affairs experience in biotechnology, with focus on biologics/advanced therapies
- In-depth knowledge of FDA and EMA regulations and guidelines
- Experience preparing and submitting INDs, BLAs/NDAs, and MAAs
- Strong project management and leadership skills
- Excellent written and verbal communication abilities
Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.
Ryan Griffin
Submit Your CV
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