Regulatory Affairs Specialist

REGULATORY AFFAIRS SPECIALIST

6 MONTH CONTRACT

£45 PER HOUR

SUFFOLK

A WORLD-LEADING PHARMACEUTICAL COMPANY are looking for a talented REGULATORY AFFAIRS SPECIALIST to join their team. The successful individual will manage the onboarding process of a new manufacturer from a regulatory perspective.

SKILLS REQUIRED:

- Degree or equivalent
- Experience within a manufacturing/plant environment is a necessity
- Regulatory affairs & compliance experience in EU and International markets
- Proven ability of managing regulatory projects in EU and International markets
- Experience workingwith external manufacturers
- Knowledge of GMP.
- Good communication skills on an international basis

KEY RESPONSIBILITIES:

- Project managing a new 3rd party manufacturer
- To prepare CMC components insupport of variations in EU and International markets
- variations and dossiers are prepared and delivered according to planned regulatory strategies in both the EU and International markets
- Work with both internal and external regulatory functions