Global Regulatory Affairs Leader for Pharmaceutical Development

1 day ago

Lexington, Kentucky, United States Takeda Pharmaceutical Full time

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Our team is committed 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.

About the Opportunity

This leadership role will be responsible for developing and executing regulatory strategies for assigned products as Global Regulatory Affairs Product Lead. The ideal candidate will have a proven track record of success in leading major submissions during Life Cycle Management (LCM), development, and post-market support. This includes preparation of NDA/NLA/MAA documents.

  • The selected candidate will represent Takeda GRA CMC in Health Authority meetings and drive preparation activities for meetings with Health Authorities on CMC related matters.
  • Guiding the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirements.
  • Demonstrating emerging leadership, problem-solving ability, flexibility, and values teamwork.
  • Developing and executing global regulatory submissions through product lifecycle.
  • Providing global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.
Responsibilities

The successful candidate will be accountable for:

  • Developing and executing global regulatory strategies for assigned products.
  • Leading cross-functional teams to ensure effective strategies are implemented and project execution is on target.
  • Representing Takeda GRA CMC in Health Authority meetings and driving preparation activities for meetings with Health Authorities on CMC related matters.
  • Guiding the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirements.
  • Developing and maintaining relevant regulatory documentation.
Requirements

To be considered for this opportunity, candidates must meet the following qualifications:

  • BS/BA Degree in a Scientific Discipline, Advanced Degree required.
  • 10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and/or devices experience, while leading major submissions during LCM, development – including preparation of NDA/NLA/MAA documents.
  • Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
  • Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
  • Able to deal with issues of critical importance with minimal oversight.
Compensation and Benefits

Takeda offers a competitive salary range of $169,400 - $266,200 per year, depending on qualifications and experience. In addition to salary, U.S.-based employees may be eligible for short-term and long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits. U.S.-based employees are also eligible to receive up to 80 hours of sick time and new hires accrue up to 120 hours of paid vacation.

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