Regulatory Affairs Director
4 days ago
Confidential
Nordics - Stockholm
Pioneering Leadership Role in Regulatory Affairs
Job Overview: We are seeking a visionary Senior Director Regulatory Affairs to spearhead regulatory strategies and lead the establishment of a new pharmaceutical portfolio for a pioneering company in consumer health. This is an exceptional opportunity to drive impactful change and make a lasting impact.
About the Company: Our client is an innovative leader in the consumer health space, expanding into the pharmaceutical industry. As they embark on this exciting journey, we need an experienced Senior Director Regulatory Affairs to establish and lead regulatory strategies, particularly for OTC products.
Key Responsibilities:
- Develop and implement tailored regulatory strategies for OTC products across the Nordics.
- Critically evaluate submission packages to ensure compliance with Nordic regulatory standards.
- Monitor and influence the assessment process to expedite approvals and optimize outcomes.
- Ensure compliance by communicating any regulatory changes to the global team.
- Submit and maintain local medicinal product information.
Requirements:
- Lifescience Degree or equivalent, with broad regulatory experience in medicinal products.
- Minimum 10 years in regulatory activities, with a focus on OTC products and commercial aspects.
Skills:
- Strong negotiation and regulatory compliance skills.
- Proven leadership experience with a business-minded approach.
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