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Regulatory Affairs Director
2 days ago
We are seeking an experienced Senior Director Regulatory Affairs to lead our regulatory strategies and drive compliance across the Nordics.
Main Responsibilities:- Develop and implement tailored regulatory strategies for OTC products in the Nordic region.
- Ensure submission packages meet Nordic regulatory standards, eliminating deficiencies prior to submission.
- Monitor and influence assessment processes to expedite approvals and optimize outcomes, including product labeling and supply continuity.
- Communicate regulatory changes to the global team and address critical issues such as batch recalls or release challenges.
- Submit and maintain local medicinal product information, including Patient Information Leaflets, SmPCs, packaging texts, RMPs, and Educational Material as needed.
Key Skills:
- Broad regulatory experience in medicinal products, preferably in OTC products and commercial aspects within the pharmaceutical industry.
- Strong negotiation and regulatory compliance skills, as well as proven leadership experience with a business-minded and detail-oriented approach.
- Proficiency in a local Nordic language and English is essential.
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