Associate Director Global Regulatory Affairs CMC
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will be responsible and accountable for Regulatory CMC development, registration and post-approval strategies. You will communicate and negotiate with international Health Authorities, directly and indirectly. You will ensure global strategies are accomplished across both new product development and existing portfolio life cycle management. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.How you will contribute:
- Independently manage regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities.
- Member of global teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance.
- Recommend direction for essential operations and new programs in collaboration with local and global team members.
- Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.
- Develop staff, if required, including staff professional development and project oversight.
- Represent Takeda Regulatory Affairs CMC in Health Authority meetings and lead preparation activities for meetings with Health Authorities on CMC related matters.
- Interact directly with international Health Authorities. Participate in and facilitate agency meetings.
- Ensure project team colleagues, line management, and partners are informed of developments that may affect regulatory success. Provide solutions to prevent recurrence of issues.
- Stay up-to-date with current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and shares experience with others to support their development.
- Maintain constructive relations with essential colleagues, eg colleagues within Takeda, Alliance Partners, and Health Authority representatives.
- Evaluate new business development opportunities or participate on due diligence teams.
- Evaluate change proposals for global regulatory impact and plan global variations and amendments.
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 8+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (eg, Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
- Experience with pharmaceutical development of active pharmaceutical ingredient/drug substances or drug products, analytical characterization, process scale-up or regulatory registration of products is required.
- Experience with global regulatory aspects of CMC involving undefined frameworks with medium technical complexity and defined scope. Experience liaising 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.
- Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams. Provide regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Demonstrate leadership, problem-solving ability, flexibility and values teamwork.
- Demonstrated ability to work well within a matrix structure in a complex environment.
- Exercise good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues.
- Excellent written and oral communication skills required.
- Active participation in Agency/Industry groups/forums preferred.
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement
This position is currently classified as hybrid in accordance with Takeda's Hybrid and Remote Work policy.
Base Salary Range: $137,000 to $196,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives 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.Empowering our people to shine:
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.
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.Locations Boston, MALexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time