Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Material Science Expert
4 days ago
Takeda Pharmaceutical is seeking a highly skilled and experienced Senior Director and Regulatory Platform Lead to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of innovative regulatory strategies for CMC and device-drug combinations.
Key Responsibilities:
- Develop and implement regulatory strategies for CMC and device-drug combinations
- Lead cross-functional teams to ensure regulatory compliance and success
- Collaborate with global health authorities to ensure regulatory submissions are of high quality and right first time
- Establish and maintain relationships with key stakeholders, including regulatory agencies and industry partners
- Provide tactical regulatory guidance to product teams and develop strategies, tools, and trainings to develop the combination product regulatory team
Requirements:
- 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
- Experience working on cross-functional teams, leading and influencing on regulatory positions, to set programs on course for regulatory success
- 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
What We Offer:
- Competitive salary and benefits package
- Opportunities for professional growth and development
- Collaborative and dynamic work environment
- Recognition and rewards for outstanding performance
How to Apply:
Interested candidates should submit their resume and cover letter to [insert contact information]. We thank all applicants for their interest; however, only those selected for an interview will be contacted.
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