Technical Regulatory Advisor GRA CMC, Drug-Device Combinations US
5 days ago
Takeda Pharmaceutical is seeking a highly skilled Regulatory Advisor to join our team in Boston, MA. As a key member of our Global Regulatory Affairs (GRA) team, you will play a critical role in shaping our regulatory strategies for device and combination product development, registration, and post-market support in the US.
Key Responsibilities:
- Develop and implement innovative regulatory strategies for device and combination product development, registration, and post-market support in the US.
- Provide technical expertise and guidance on regulatory requirements relevant to global drug-device combination product development, registration, and post-market support.
- Collaborate with cross-functional teams to ensure regulatory filings are of high quality and right first time.
- Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations.
- Interface with regulatory agencies and trade associations to influence changing regulations and guidance documents.
Requirements:
- BS/BA Degree in a Scientific, Pharmaceutical, or Engineering Discipline, higher degree preferred.
- 10+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience as a regulatory representative for device and combination products in the US.
- Experience working on cross-functional submission teams.
- Solid understanding and proven ability to provide strategy on regulatory requirements relevant to global drug-device combination product development, registration, and post-market support.
What We Offer:
- Competitive salary range: $205,100.00 - $322,300.00.
- Short-term and long-term incentives.
- Medical, dental, vision insurance.
- 401(k) plan and company match.
- Short-term and long-term disability coverage.
- Basic life insurance.
- Tuition reimbursement program.
- Paid volunteer time off.
- Company holidays.
- Well-being benefits.
EEO Statement:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, and local laws, and any other characteristic protected by law.
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