Director, GRA CMC- Cell & Gene Therapy

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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 a Director Global Regulatory Affairs CMC - Cell and Gene Therapies where you will oversee the development and execution of regulatory CMC development and registration strategies. As part of the Global Regulatory Affairs CMC team, you will report to the Executive Director and work with Regulatory, Pharmaceutical Development, and Production project teams.

• Demonstrate Takeda leadership behaviors.

• Independently manage regulatory submissions for assigned compounds in primarily the early phases of clinical development.

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

• Evaluate change proposals for regulatory impact and filing requirements.

• Develop regulatory CMC strategies for the assigned compounds.

• Lead and contribute to business process development.

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

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

• Ensure that project team colleagues, line management, and partners are informed of developments that may affect regulatory success.

• Elevate and communicate actual or potential issues to line management.

• Successfully communicate and negotiate with international Health Authorities, directly and indirectly.

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

• Manage and support staff, if required, including staff professional development and project oversight.

• BS/BA 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 and prior experience working on cell and gene therapies strongly preferred.

• Experience liaising 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.

• Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.

• Ability to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.

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

• Good judgement 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.

• 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

What Takeda can offer you:

• 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

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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not

Permitted to Apply.

The position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy

Base Salary Range: $156,800 to $224,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. 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.  

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

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.

Massachusetts - Virtual

Employee

Regular

Full time

#LI-Remote

About the Company:
Takeda Pharmaceutical

Salary : $156,800 - $224,000