Requirements: English
Company: TN Switzerland
Region: Aubonne , Vaud
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Regulatory Compliance Specialist (m/f/d), Aubonne
Client:
Location:
Job Category:
Other
Job Reference:
c19cabb6f287
Job Views:
3
Posted:
02.04.2025
Expiry Date:
17.05.2025
Job Description:
As an integral member of our Quality Unit, you will be accountable for:
- Change control assessment and compliance of manufacturing activities vs regulatory filing.
- Provision of regulatory documents and regulatory intelligence.
- Local expertise in Regulatory Affairs.
Your role includes:
- Reviewing and assessing changes reportability to health authorities and approving minor changes.
- Reviewing and approving any relevant GMP documentation against applicable regulatory filings and marketing authorizations.
- Coordinating collation of regulatory deliverables (data/documents) to support regulatory submissions and assist in the Answers to Objections of Health Authorities.
- Being responsible for some technical regulatory writing (in CTD format).
- Coordinating local review of regulatory CMC modules of the registration file.
- Bringing the attention of the Site QA any new compendial or revised monographs concerning regulatory procedures or any compendia product monograph, new Health Authority guidelines or inquiry (regulation compliance) and providing support for appropriate and timely implementation to ensure compliance.
Who you are:
- Biologist, pharmacist or other Life Science-related discipline with relevant experience in biotechnological manufacturing.
- Training or education in regulatory with experience in interaction with regulatory agencies.
- Fluently spoken and written English and French; a third European language would be an advantage.
- Good editorial and communication skills.
- Strong organizational, structural, and coordination abilities.
- Known for being purposeful, result-driven, and collaborative.
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