Regulatory Affairs Manager

Walker Cole International is searching for a Regulatory Affairs Manager to join a global pharmaceutical company. As the Regulatory Affairs Manager you will be responsible for EU regulatory activities including lifecycle management, submissions to EU regulatory bodies, preparing for new MAAs and developing regulatory strategy (throughout product lifecycle).

The main responsibilities of the Regulatory Affairs Manager will include:

• Module 1 compilation, artwork management & approvals, submission of new Marketing Authorizations.
• Pro-actively contributing to regulatory strategic development (EU) from the initial phase of development until dossier submission.
• Line management of a small team.

The successful candidate will:

• Proven experience with EU markets and have a great understanding of relevant EU regulations for medicinal products.
• Proven experience in creating RA strategies for new MAAs and VA submissions.
• Has direct line management experience (3-5 people).
• Good communication skills.

Regulatory Affairs | RA | GMP | Pharmaceutical | Regulatory | Submission | Dossiers | EU | Global | EMA | Good Manufacturing Practice | CTD | Common Technical Documentation | eCTD | Electronic Common Technical Documentation | Module 1 | MAA | Marketing Authorization Application | Variations | SmPC | Summary of Product Characteristic | PIL | Product Information Leaflet