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Job Description

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, e.g. 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.

What you bring to Takeda:

• 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 (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 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.

At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global 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

Discover more at takedajobs.com

At our heart are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, race or ethnic origin or disability. Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

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