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Regulatory Affairs

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Regulatory Affairs Specialist

Locations: Beerse, Belgium
Functions: Regulatory Affairs
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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
Consumer & Personal Care
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Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Employment Opportunity Posters

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please complete the form below. If you'd like to view a copy of the company's affirmative action plan, please complete this form.

This site is governed solely by applicable U.S. laws and governmental regulations. Please see our Privacy Policy. Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy. Your use of the information on this site is subject to the terms of our Legal Notice. You should view the News section and the most recent SEC Filings in the Investor section in order to receive the most current information made available by Johnson & Johnson Services, Inc. Contact Us with any questions or search this site for more information.
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Regulatory Affairs

Contract Type: 
Permanent contract
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