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Director of Regulatory Affairs
8 hours ago
PharmaRelations ApS Overview
We are a leading Sales, Marketing and Distribution company in Sweden with a vision to make brands more successful.
Job Description
The Senior Director Regulatory Affairs will take ownership of regulatory activities across various areas, including MAs (MRP/DCP and national licenses), and oversee the marketing of cosmetics, medical devices, and food supplements across the Nordics.
Main Responsibilities:
- Collaborate with the MAH's global team and local colleagues to develop and implement regulatory strategies tailored to the Nordic region.
- Critically evaluate submission packages to meet Nordic regulatory standards, eliminating deficiencies prior to submission.
- Monitor and influence the assessment process to expedite approvals and optimize outcomes, including product labeling and supply continuity.
- Ensure compliance by communicating any regulatory changes to the global team and addressing 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.
- Lead the management of new MA submissions in collaboration with the global team, supporting Scientific Advice meetings, launches, and readiness initiatives.
- Provide strategic regulatory advice for divestments and in-licensing opportunities, considering Nordic-specific perspectives.
Qualifications
- Education: Life Science Degree or equivalent, with broad regulatory experience in medicinal products. Experience in food supplements, cosmetics, and medical devices is advantageous.
- Experience: Minimum of 10 years in regulatory activities, with a focus on OTC products and commercial aspects within the pharmaceutical industry.
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