J&J Family of Companies Regulatory Affairs Specialist in Beerse, Belgium
You are a regulatory affairs expert for a broad range of regulatory activities for registered products, cosmetics and medical devices in the Benelux.
We are looking for a talented person who can manage a defined product portfolio and will work closely with local peers and regional project teams.
The ideal candidate brings a level of experience within the Benelux regulatory affairs environment. The candidate has problem-solving capabilities that enable successful development of local strategies and brings technical solutions to support the business. The candidate has excellent interpersonal, negotiation and communication skills.
Ensure marketing authorisations and lifecycle management compliant with regulatory requirements
Prepare and manage local submissions, assure timely execution and compliance
Prepare artwork, manage proofreading for launch
Ensure timely and pro-active communication of the authorisation status within the organisation.
Build and sustain a positive relationship with the health authorities
Follow-up of regulatory legislation; evaluate impact on business
Provide regulatory requirements and intelligence to Regional and European organisation
University degree – medical or paramedical (pharmacy, biology, veterinary, biomedical sciences) or equivalent by experience
Knowledge of Benelux pharmaceutical legislation and experience in EU regulatory procedures is an advantage
Experience of working in cross-functional teams, working in a matrix organisation
Excellent oral and written communication skills
Fluent English, French and Dutch (speaking, reading and writing), basic understanding of German.
Johnson & Johnson N.V./S.A. (7821)