
Regulatory Strategy Specialist
9 hours ago
- Regulatory Strategy Development:
- Supports the company organization with regulatory strategic knowledge.
- Assists with the development of standards for operating procedures.
- Policy Monitoring:
- Keeps up to date with relevant regulations and provides recommendations to the leadership team.
- Supports the company in implementing new requirements accordingly.
- Cross-functional Collaboration:
- Supports and ensures review and management of internal approval of marketing material, from a regulatory point of view (varies a lot but in peak periods it can be 60% of the workload).
- Communication with external partners:
- Main contact for partner companies and competent authorities in matters of regulatory for both medicinal products and medical devices.
- Prepares and submits applications and reports to applicable regulatory agencies as requested by the MAH/product suppliers. Responds to requests for information from regulatory bodies.
- Assists MAH/product supplier with local linguistic and regulatory review of product texts (SPC and PIL) and artwork.
- MSc of Pharmacy or other relevant degree in natural sciences.
- Minimum 2 years of experience from Regulatory Affairs.
- 2-5 years' experience within marketing compliance.
- Strong knowledge of regulations for medicinal products and/or medical devices.
- Excellent communication and interpersonal skills.
- Proven ability to lead regulatory submissions and interactions with regulatory agencies.
- Fluent in Swedish and English.
- Merit: Experience from both MedTech and the pharmaceutical industry.
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