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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