- Manage regulatory deliverables for medical devices and drug-device combinations.
- Ensure regulatory consistency across Self Care brands.
- Develop strong partnerships with R&D, Marketing, and local businesses.
- Oversee product lifecycle maintenance.
- Represent Regulatory Affairs within the Self Care Franchise.
- Provide regulatory input and guidance to product development teams.
- Support business initiatives and influence product portfolio decisions.
- Conduct regulatory risk assessments and ensure compliance with local requirements.
- Lead inspections and manage internal and external audits.
- Relevant bachelor's degree or higher.
- Expertise in medical devices and regulatory frameworks.
- OTC/Consumer Health background highly desirable.
- SaMD regulation high desirable
- Strong leadership and coaching skills.
- Excellent communication and interpersonal abilities.
- Proficiency in English.
- A dynamic, results-driven environment.
- Opportunities to influence regulatory strategies at the EU and local levels.
- A collaborative, multi-cultural team.
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Regulatory Affairs Manager - England, United Kingdom - MSI Pharma
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Description
We are seeking a dynamic and experienced professional to join our client's team as a Manager of Regulatory Affairs (RA) with a passion for innovation in the Self Care industry. You will lead a team responsible for the development of regulatory strategies and provide technical guidance across the EMEA region. The role is hybrid and will be based in the South-East of England.
Key Responsibilities:
Your Role:
Qualifications and experience:
What our client Offer:
Why Join Our Client:
As a world-leading consumer health company, you will play a pivotal role in shaping the future of healthcare through innovative regulatory strategies. If you're a visionary leader passionate about regulatory affairs and committed to excellence, this could be the ideal role.
Please send your latest resume and a cover letter outlining your experience and vision for the role or call for further information.
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