Regulatory Affairs Coordinator
Novasep
Chasse-sur-Rhône , France
Reporting to the Regulatory Affairs Manager, your main tasks will be:
- Updating registration dossiers with a view to obtaining and maintaining marketing authorisations for active substances for pharmaceutical use for our French sites on the global market (EU/US/Japan/Korea/Brazil/China/Canada).
- Drafting modules 1-2-3 of regulatory dossiers (DMF, CEP, IND, IMPD).
- Identifying and gathering the information needed to draw up and update chemical and biological regulatory dossiers.
- Answering questions from customers and regulatory authorities.
- Participate in the registration of sites with the various health authorities: France (MPUP and pharmaceutical establishment), US, Japan.
- Assess requests for changes and anomalies from a regulatory point of view.
- Keeping a regulatory watch and reviewing compliance with current dossiers.
You will also be actively involved in the day-to-day work of the regulatory affairs department at the production sites, and will be asked to take part in the continuous improvement projects deployed at the sites.
Qualifications:
With an initial background in chemistry or biology and a 5-year degree in higher education or a pharmacist's diploma with a specialisation in Regulatory Affairs, you will have an initial successful experience in Regulatory Affairs, ideally in Drug Substance or Drug Product. Experience in biological products (MAb, ADC, etc.) would be a plus.
You will be rigorous, organised, dynamic, creative, autonomous and a team player. You will be able to put forward proposals to help us achieve our objectives. You have a good sense of priorities and results, good interpersonal and communication skills.
Professional English required.
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