Regulatory Affairs Director
3 days ago
At Takeda Pharmaceutical, we are seeking an experienced Associate Director, Global Regulatory Affairs to join our team in Cambridge, MA.
Job Summary:
We are looking for a highly skilled and motivated individual to lead our global regulatory strategy and ensure compliance with regulatory requirements. The successful candidate will have a strong background in regulatory affairs, with experience in leading global projects and interacting with health authorities.
Key Responsibilities:
- Develop and implement global regulatory strategies for late-stage development projects
- Provide regulatory oversight and execute regulatory activities for multiple indications and device platforms
- Lead global health authority interactions, including preparation meetings with FDA, EMA, and other regulatory bodies
- Develop high-level global regulatory supplemental biologic application (sBLA) strategy and lead global cross-functional submission working groups
- Collaborate with global regulatory teams to ensure multiple global pre-submission meetings and marketing application submissions
Requirements:
- Master's degree in Pharmacy, Biomedical Engineering, Regulatory Affairs, or related field
- 7+ years of related experience in regulatory affairs, with a strong background in immunology and inflammation therapeutic franchise
- Proven experience in leading global projects and interacting with health authorities
- Strong communication and leadership skills
What We Offer:
- Competitive salary and benefits package
- Opportunity to work with a global pharmaceutical company
- Collaborative and dynamic work environment
How to Apply:
Apply online at [insert link] and search for Req # [insert number].
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