By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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 a Senior Director, Global Regulatory Affairs CMC where you are accountable for the development and execution of regulatory CMC risk strategy. You will manage staff members. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff.

How you will contribute:

• Combines the knowledge of scientific, technical, regulatory, and business issues to drive and execute global product strategy throughout the development and commercial lifecycle.

• Demonstrate Takeda leadership behaviors.

• Globally influences and is considered a key opinion leader within Takeda and externally.

• Participate in global teams that require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance.

• Influences changing regulations and guidance, interfaces with outside regulatory agencies and trade associations, and acts as an advisor/liaison to senior management to plan, evaluate and recommend a regulatory strategy.

• Ensures team effectiveness in a complex matrix environment.

• Able to deal with issues of critical importance provide regulatory advice and make reasoned decisions for which there may not be clear/specific regulatory guidance.

• Demonstrates Takeda leadership behaviors in leadership, problem-solving ability, flexibility, and teamwork.

• Quick to adapt strategies based on regulatory and business need changes.

• Acts as CMC regulatory expert for developing regulatory advice on complex topics and sharing with influence to global project teams/task forces.

• Builds and manages relationships through active partnering with key internal and external stakeholders.

• Lead and contribute to department and business process improvements.

• Evaluate new business development opportunities or represent Global Regulatory Affairs CMC on due diligence teams.

• Ensure that project team colleagues, line management, and partners are informed of developments, risks, and opportunities that may weigh on regulatory success.

• Elevate and clearly communicate actual or potential issues to stakeholders and management.

• Demonstrated track record for successful interactions with FDA and other global health authorities related to CMC submissions.

• Represent Takeda Global Regulatory Affairs CMC in Health Authority meetings and lead CMC preparation activities for meetings with Health Authorities on CMC-related matters.

• Significant staff management experience for staff professional development, as well as leading submission teams for marketing applications, clinical trial applications, and life cycle management.

What you bring to Takeda:

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

• 15+ years of pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience, strongly preferred.

• proven experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.

• Expert 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.

• Provides regulatory advice and is able to make/communicate difficult decisions.

• Demonstrated leadership, problem-solving ability, flexibility, and teamwork.

• Excellent judgment in elevating and communicating actual or potential issues to line management.

• Excellent written and oral communication skills.

• Experience of active participation in Agency/Industry groups/forums expected.

Travel Requirements:

• Willingness to travel to various meetings, including overnight trips.

• Requires approximately up to 10-30% travel.

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.

Locations

Worker Type

Worker Sub-Type

Time Type