Senior Regulatory Affairs Professional – GRA EMEA, Haematology
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Beerse • Belgium
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Job Level
About the role
- Guide project teams on regulatory requirements and contribute to regional and local regulatory strategies.
- Support the EMEA Regulatory Leader in developing regulatory strategies for products in product development.
- Assist in submissions to health authorities, including CTAs, MAAs, and lifecycle submissions.
- Contribute to Global Regulatory and cross-functional meetings as the EMEA Regulatory Professional.
- Draft and review document content based on regulatory knowledge.
- Review clinical trial protocols to ensure alignment with regulatory requirements.
- Provide guidance on CTA submission strategies and documents such as protocols and Investigator’s Brochures (IB).
Requirements
- Bachelor’s degree (BS) in life sciences, medical, or paramedical fields (e.g., pharmacy, biology, veterinary science), or equivalent experience.
- A Master’s degree (MS), MBA, or higher qualification is considered a plus.
- Experience in pharmaceutical industry or similar and / or Regulatory Affairs 3–4 years of regulatory experience,
- Experience working in cross-functional teams
- Strong oral & written communication skills in English
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory requirementsregulatory strategiessubmissions to health authoritiesclinical trial protocolsCTA submission strategiesdocument draftingdocument review
Soft Skills
communication skillscross-functional teamwork
Certifications
Bachelor’s degreeMaster’s degreeMBA