Regulatory Affairs Specialist
il y a 1 jour
ProductLife Group, a leading international consulting firm in the life sciences industry, is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a key role in ensuring the compliance of our clients' products with regulatory requirements in France, Europe, and the US.
Key Responsibilities:- Participate in the development of regulatory strategies for our clients' products
- Accompany the preparation of regulatory dossiers, including Module 3, Quality Overall Summary, and IMPD
- Prepare, write, and compile regulatory documents, including Module 3, Quality Overall Summary, and IMPD
- Examine and evaluate the compliance of regulatory documents with current regulations and guidelines
- Act as a point of contact for our clients with regulatory agencies, including ANSM, EMA, and FDA
- Pharmacist or Master's degree in Life Sciences
- Minimum 10 years of experience in regulatory affairs, including experience with Module 2.3 and Module 3
- Knowledge of regulatory requirements in France, Europe, and the US
- Rigorous and autonomous individual with strong analytical and writing skills
- Excellent communication and interpersonal skills
- Dynamic and stimulating work environment
- Opportunities for professional growth and development
- Competitive salary and benefits package
- Telecommuting options
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