Director, Global Regulatory Affairs CMC - Now Hiring

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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 - Biologics where you will oversee the development and execution of regulatory CMC development and registration strategies. You may manage staff members. As part of the Global Regulatory Affairs CMC team, you will report to the Executive or Senior Director and work with Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff.

• Demonstrate Takeda leadership behaviors.

• Independently manage regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities.

• 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.

• Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements.

• 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 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.

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

• Requires approximately up to 10-30% travel.

Location and Salary Information:

Base Salary Range: $156,800- $224,000 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.

• 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

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.

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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Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.

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.