Regulatory Affairs Specialist
vor 1 Tag
We are seeking an experienced Associate Director to lead our Device and Drug-Device Combinations EU and Global Markets team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing innovative regulatory strategies for our combination product portfolio.
Key Responsibilities- Develop and implement regulatory strategies for combination products in EU and Global Markets
- Provide regulatory guidance to product teams and serve as device lead for EU and Global Markets post-approval regulatory assessments
- Identify and mitigate regulatory risks, ensuring timely communication with line management
- Support and lead regulatory submissions, including IMPDs, MAAs, and Variations
- Collaborate with cross-functional teams to ensure effective strategies are implemented and project execution is on target
- BS/BA Degree in a Scientific, Pharmaceutical, or Engineering Discipline
- 8+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience as a regulatory representative for drug-device combination products in EU & Global Markets
- Experience working on cross-functional submission teams and supporting interactions with EMA, Notified Bodies, and other global health authorities
- Demonstrated leadership, problem-solving ability, flexibility, and teamwork
Takeda offers a dynamic and supportive work environment, with opportunities for professional growth and development. We are committed to diversity, equity, and inclusion, and strive to create a workplace that is welcoming and inclusive for all employees.
Travel RequirementsThis role requires approximately 10% travel, including overnight trips and some international travel.
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