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Regulatory Affairs Director
18 hours ago
As a Senior Director of Regulatory Affairs, you will be responsible for shaping regulatory strategies and building a new pharma portfolio for a leader in consumer health. This role requires a strategic leader with a business-minded approach to ensure compliance and promote innovative solutions.
About the Company
Our client is one of the leading Sales, Marketing, and Distribution companies in Sweden, committed to making brands more successful. They are seeking an experienced Senior Director Regulatory Affairs to establish and lead regulatory strategies for OTC products as they build their pharmaceutical portfolio.
Main Responsibilities
- Develop and implement regulatory strategies tailored to the Nordic region in collaboration with the MAH's global team and local colleagues.
- Critically evaluate submission packages to meet Nordic regulatory standards, ensuring no deficiencies prior to submission.
- Monitor and influence the assessment process to expedite approvals and optimize outcomes, including product labeling and supply continuity.
Requirements
- Education: Life Science Degree or equivalent, with broad regulatory experience in medicinal products.
- Experience: Minimum of 10 years in regulatory activities, with a focus on OTC products and commercial aspects within the pharmaceutical industry.
- Skills: Strong negotiation and regulatory compliance skills, proven leadership experience, knowledge of promotional compliance, and proficiency in a local Nordic language and English.
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