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Job Description

About the role:

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 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 will review this content for conformance with the 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 the recurrence of issues.

• Stay up-to-date with current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and share experience with others to support their development.

• Maintain constructive relations with essential colleagues, e.g. colleagues within Takeda, Alliance Partners, and Health Authority representatives.

• Evaluate new business development opportunities or participate in due diligence teams.

• Evaluate change proposals for global regulatory impact and plan global variations and amendments.

Minimum Requirements/Qualifications:

• BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.

• 8+ years of pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (e.g., 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 make 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 judgment in elevating and communicating actual or potential issues to line management and present solutions to those issues.

• Excellent written and oral communication skills are required.

• Active participation in Agency/Industry groups/forums is preferred.

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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