Associate Director, Global Regulatory Lead, GRAD Oncology
Job Level: Senior
Travel: Minimal (if any)
About Takeda: Takeda has been translating science into breakthrough medicines for 240 years. Our teams work together to tackle some of the most challenging problems in drug discovery and development. Today, Takeda is a driving force behind innovative therapies that make a lasting difference to millions of patients globally. In R&D, diversity of thought is welcomed, and every voice is amplified. Join a team that has earned trust for more than two centuries and help advance transformative therapies to shape a bright future.
About the Role: As Associate Director, Global Regulatory Lead, GRAD Oncology, you will provide strategic and tactical regulatory advice to teams to ensure the efficient development and maintenance of programs while maintaining compliance with applicable regulatory requirements. You will define, develop, and lead global regulatory strategies for complex or multiple projects.
How You Will Contribute:
Define and lead global strategies to maximize regulatory success for complex/multiple projects.
Provide strategic and tactical advice for efficient development and maintenance of programs.
Lead Global Regulatory Teams (GRTs) and sub-working groups like Label Working Groups.
Represent GRTs at project team meetings and provide tactical guidance to ensure updated and executed regulatory strategies.
Serve as a global and/or regional regulatory lead as a member of a GRT.
Ensure effective implementation of global regulatory strategies aligned with regulatory and business changes.
Communicate project developments to colleagues, line management, and stakeholders professionally and timely.
Anticipate regulatory risks, develop solutions, and discuss strategies with teams and management.
Lead and manage all FDA submission activities, including meetings and approvals for assigned projects.
Oversee global regulatory submissions ensuring compliance with local regulations.
Manage vendor regulatory activities and submissions.
Lead or support regulatory due diligence for licensing opportunities.
Partner with Global Market Access for regulatory interactions with HTA bodies on value evidence topics.
Monitor and anticipate regulatory and access trends to refine development plans and strategies.
Demonstrate and uphold Takeda leadership behaviors.
Minimum Requirements/Qualifications:
Bachelor’s degree required; advanced degree (PharmD/PhD/MD) strongly preferred.
8+ years of experience in the pharmaceutical industry, including regulatory and/or related fields.
Experience in reviewing, authoring, or managing regulatory submission components preferred.
Solid working knowledge of drug development processes and global regulatory requirements (FDA, EU, Canada, ROW).
Ability to interpret complex scientific data for regulatory requirements and strategy.
Strong oral and written communication skills.
Ability to work independently with acceptable skills in regulatory strategy development.
Team player capable of bringing together cross-functional teams for common objectives.
Skilled in identifying regulatory issues and offering creative solutions and risk mitigation strategies.
About Us: Takeda is transforming patient care through the development of novel specialty pharmaceuticals and top-tier patient support programs. Certified as a Global Top Employer, Takeda offers stimulating careers, promotes innovation, and fosters a collaborative, inclusive workplace. Employees are united by a commitment to deliver Better Health and a Brighter Future.
Compensation and Benefits:
Location: Boston, MA
U.S. Base Salary Range: $153,600.00 – $241,340.00
Actual base salary will depend on qualifications, experience, skills, education, certifications, and location.
U.S.-based employees may be eligible for incentives, medical, dental, vision insurance, 401(k) with company match, disability coverage, basic life insurance, tuition reimbursement, paid volunteer time, holidays, well-being benefits, up to 80 hours of sick time, and up to 120 hours of vacation annually.
EEO Statement: Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, veteran status, or any other characteristic protected by law.
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