Regulatory Affairs Manager and Specialist

REF.: 105856

PPD

Vlaams Brabant 06 februari 2012

PPD

PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations.

Regulatory Affairs Manager and Specialist

Functieomschrijving

We are seeking a Regulatory Affairs Manager and a Specialist to join our team in our Brussels office.

The Regulatory Affairs Manager is required to provide regulatory advice on strategy and manage projects in the provision of Regulatory Affairs Services. To liaise with internal and external clients in the provision of marketing these services.

Duties & Responsibilities of Manager:
- To provide project specific regulatory services & co-ordination of these projects
- To provide regulatory strategy and product development advice to internal & external clients
- To review & prepare regulatory submissions
- To manage project budgeting/forecasting
- To provide regulatory advisory and training service for regulatory affairs within the company
- Maintain knowledge of and understand PPD SOP's, Client SOPS's/directives and current regulatory guidelines regarding clinical trials, regulatory documents and other regulatory submissions.
- To manage other regulatory affairs individuals as necessary including leading and training a small group of regulatory professionals as appropriate.
- To assist in business development and pricing of projects for Regulatory Affairs in the company
- Other Duties as required

Profiel

Ideally candidates will have a degree or equivalent) in Pharmacy or Life Sciences, a higher qualification in a relevant subject and/or post-graduate courses in Regulatory Affairs would be an advantage. Good knowledge of European Regulatory Procedures and knowledge of European country specific clinical trial application procedures would be advantageous.

With offices in 44 countries and more than 11,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.