Senior Regulatory Affairs Specialist
Há 1 mês
At Biom?Rieux Bv, we are seeking a highly skilled Sr. Scientist, Regulatory Affairs to join our team. The ideal candidate will have a strong background in regulatory chemistry, manufacturing, and controls (CMC) and be able to develop and implement global regulatory strategies for assigned products.
Key Responsibilities:
- Develop and execute global regulatory strategies for assigned products.
- Prepare and review information required for the development of regulatory CMC dossiers.
- Collaborate with cross-functional teams to ensure product compliance.
- Assess and communicate potential regulatory risks.
- Manage multiple projects to ensure timely submissions.
Requirements:
- Bachelor's or advanced degree in a science, engineering, or related field.
- Minimum 2 years of relevant CMC experience.
- Strong analytical and communication skills.
- Experience with regulatory guidelines and documentation.
Preferred Qualifications:
- Direct experience in Regulatory CMC and/or authoring of regulatory documentation.
- Device and/or combination product regulatory experience.
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