Regulatory Affairs Expert for Women's Health Solutions
1 semana atrás
Job Description
Sr. Scientist, Regulatory Affairs - Chemistry, Manufacturing & Controls (CMC)
The Senior Scientist in this role will be responsible for implementing Regulatory Strategies for assigned products in accordance with global regulations and defined regulatory strategies.
Key Responsibilities:
- Provide input to global product and project regulatory strategies by assessing CMC changes and identifying global regulatory requirements.
- Execute global regulatory strategies by leading the development of CMC submission components and documentation.
- Maintain timely and accurate CMC submissions in systems to ensure product compliance.
- Liaise with Manufacturing & Supply colleagues and external partners to support compliant execution of change management.
- Assess and communicate potential regulatory risks and propose mitigation strategies.
Requirements
This position requires a strong background in Chemistry, Biochemistry, Chemical Engineering, Biology, Pharmacy, Microbiology, Virology, or Molecular Biology. The ideal candidate should have at least 4 years of relevant work experience, including biological/pharmaceutical research, manufacturing, testing, or a related field.
Technical Skills
The candidate must be proficient in English and possess excellent oral and written communication skills. Familiarity with regulatory guidelines for product post-approval change management is essential.
Biom?Rieux Bv Values Diversity and Inclusion
We are committed to creating an inclusive environment for all our applicants. As an equal opportunity employer, we welcome applications from candidates with diverse backgrounds.
Estimated Salary: $110,000 - $140,000 per annum
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