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Senior Director and Regulatory Platform Lead for Device and Drug-Device Combinations
2 months ago
We are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products.
Key Responsibilities- Develop and implement global regulatory strategies for device and combination products, ensuring compliance with relevant regulations and guidelines.
- Provide tactical regulatory guidance to product teams on Material Sciences and allied fields for drug-device combinations.
- Collaborate with cross-functional teams to ensure effective strategies are implemented and project execution is on target.
- Lead regulatory strategy, briefing book authoring, and meetings with global health authorities.
- Review and approve medical device development design control documentation to ensure alignment with regulatory requirements and standards.
- Proactively identify combination product and device-related regulatory risks and ensure timely communication with line management.
- Support and/or lead assigned device-related aspects of global regulatory submissions.
- Provide global regulatory input and support on product-compliance related activities.
- BS/BA Degree in a Scientific, Pharmaceutical, or Engineering Discipline, Advanced Degree Preferred.
- 10+ years of experience in a device and/or combination product role in pharmaceuticals and/or medical devices industry, including experience in regulatory CMC.
- Proven expertise and experience in the area of Material Sciences and allied fields for drug-device combinations.
- Experience supporting interactions with FDA, EMA, Notified Bodies, and other global health authorities specifically related to Combination Products and Device submissions.
- Demonstrates emerging leadership, problem-solving ability, flexibility, and teamwork.
- Excellent written and oral communication skills, with cross-organization stakeholder engagement.
We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced regulatory professional looking for a new challenge, we encourage you to apply.
