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.

Key responsibilities:

  • 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

Qualifications

  • 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.

  • Positive mindset

Primary Location

Belgium-Antwerp-Beerse-

Organization

Johnson & Johnson N.V./S.A. (7821)

Job Function

Regulatory Affairs

Requisition ID

1805691080W