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Senior Regulatory Affairs Manager, CMC Small Molecules
4 weeks ago
Takeda is a patient-focused company that drives innovation in specialty pharmaceuticals and patient support programs.
We are certified as a Global Top Employer and strive for excellence in everything we do, fostering an inclusive and collaborative work environment where our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Job OverviewAs a Senior Regulatory Affairs Manager, you will oversee the development and execution of regulatory CMC strategies for assigned products. You will lead cross-functional teams to ensure CMC compliance within the organization and provide strategic regulatory guidance to drug development, registration, and post-market support teams.
You will also communicate and negotiate with international Health Authorities as necessary and represent Takeda RA CMC in Health Authority meetings.
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.
- Maintain expert understanding of global RA CMC regulations and guidelines and apply interpersonal skills to address challenges during development and commercialization.
- Lead team members in defining CMC content requirements for regulatory submissions and review this content for conformance with established requirements.
- Develop and maintain constructive relations with key internal and external colleagues, including cross-functional teams within Takeda, Alliance Partners, and Health Authority representatives.
- Evaluate new business development opportunities or participate on due diligence teams.
- Bachelor's degree in a scientific discipline, advanced degree preferred.
- 10+ years pharmaceutical Regulatory CMC experience, including experience as an RA CMC product lead or equivalent industry experience, with international experience strongly preferred.
- Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Able to deal with issues of critical importance and provide regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Demonstrates leadership, problem-solving ability, flexibility, and teamwork.
- Exercises good judgement in elevating and communicating actual or potential issues to line management.
We offer competitive compensation packages, including U.S. Base Salary Range: $169,400 - $266,200 per year. Employees may also be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan, short-term and long-term disability coverage, basic life insurance, tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.
Employees are also eligible to receive up to 80 hours of sick time per calendar year and accrue up to 120 hours of paid vacation time upon hire.
Equal Employment OpportunityTakeda is proud to provide 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.
