Johnson & Johnson Careers

Regulatory Affairs Specialist

Beerse, Belgium
Regulatory Affairs


Job Description

Requisition ID: 1905730716W

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
  • Preferred Knowledge of Benelux pharmaceutical legislation and experience in EU regulatory procedures is an advantage
  • Preferred 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
1905730716W