Director, Regulatory Affairs CMC Small Molecules
4 days ago
Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
We are seeking a highly experienced Director, Regulatory Affairs CMC Small Molecules to oversee the development and execution of regulatory CMC development and registration strategies.
Key Responsibilities:- Plan, execute, and manage regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
- Lead team members in defining CMC content requirements for regulatory submissions and reviewing this content for conformance with established requirements.
- Develop and maintain constructive relations with key internal and external colleagues, including cross-functional colleagues within Takeda, Alliance Partners, and Health Authority representatives.
- Exercise good judgement in elevating and communicating actual or potential issues to line management.
- Communicate and negotiate with international Health Authorities as necessary, directly and indirectly.
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 10+ years pharmaceutical Regulatory CMC experience, including experience as an RA CMC product lead with late stage development, international experience strongly preferred.
- Significant Small Molecule experience.
- Proven ability to liaise with Regulatory Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings, international experience preferred.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.
Takeda is a Global Top Employer, offering stimulating careers, encouraging innovation, and striving for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
What We Offer:We understand compensation is an important factor as you consider the next step in your career.
We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
U.S. based employees may be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
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