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Director, Regulatory Affairs
2 months ago
About Teva Pharmaceuticals
Teva is a global pharmaceutical leader committed to improving health and accessibility for millions worldwide. We develop and manufacture a wide range of generic and innovative medicines, including many essential medications listed by the World Health Organization. Our mission unites diverse teams across nearly 60 countries, driven by a shared purpose: making good health more affordable and accessible.
The Opportunity
We are seeking a highly motivated and experienced Director, Regulatory Affairs - Combination Products to join our Global Regulatory Affairs, CMC Biologics, Devices department. This role will provide global regulatory strategy and guidance for combination products, platform devices, and assigned marketed products, as well as those in development.
Location Flexibility
We welcome candidates based near one of our UK sites (Harlow, Runcorn) or Ireland (Waterford). We embrace a hybrid approach to home-working.
A Day in the Life
As Director, Regulatory Affairs - Combination Products, you will:
- Provide expert device-specific regulatory guidance to development and lifecycle teams by interpreting global regulatory guidelines and directives.
- Develop and communicate effective regulatory strategies for combination products and platform devices across development and post-marketing activities.
- Collaborate closely with cross-functional teams, including Digital Health, Commercial, Quality, and Combination Product Development, throughout the product lifecycle.
- Coordinate agency interactions, author submissions, and review regulatory correspondence for device-related activities.
- Lead meetings with regulatory agencies and Notified Bodies to support device-related initiatives.
- Review technical documents and provide regulatory feedback to colleagues.
- Manage multiple projects and competing timelines effectively.
- Assess regulatory requirements and filing timelines to ensure timely submission of high-quality filings.
Qualifications & Skills
The ideal candidate will possess:
- Extensive experience in Regulatory Affairs, with a focus on combination products and medical devices.
- Strong understanding of ISO, US, EU, and ICH regulatory guidelines.
- Experience with eCTD regulatory filings and knowledge of global content and regional requirements.
- Proven ability to manage multiple projects simultaneously and meet deadlines in a fast-paced environment.
- Excellent communication, interpersonal, and organizational skills.
