Associate Director, Global Regulatory Affairs Marketed Products

4 weeks ago


Étreux, Hauts-de-France, United States Takeda Pharmaceuticals Full time
About the Role

Takeda Pharmaceuticals is seeking a highly skilled Associate Director to lead our Global Regulatory Affairs Marketed Products team. As a key member of our organization, you will be responsible for defining, developing, and executing global regulatory strategies to maximize regulatory success and achieve program objectives.

Key Responsibilities
  • Lead the Global Regulatory Team (GRT) and collaborate with cross-functional teams to ensure global regulatory compliance and strategy execution.
  • Develop and implement regulatory strategies for complex and/or multiple projects, ensuring timely and efficient development and maintenance of programs.
  • Provide strategic and tactical advice to teams, exercising sound judgment and communicating effectively with stakeholders.
  • Proactively anticipate risks and develop solutions to identified risks, discussing with team and management.
  • Accountable for all US FDA submissions and approvals, overseeing direct reports or junior colleagues as needed.
Requirements
  • Bachelor's Degree, preferred; Bachelor's accepted.
  • 8+ years of pharmaceutical industry experience, inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience.
  • Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
  • Solid working knowledge of drug development process and regulatory requirements, including FDA, EU, Canada, ROW, and post-marketing.
  • Strong oral and written communication skills, with ability to manage and adhere to timelines, negotiate, and demonstrate integrity and adaptability.
About Takeda

Takeda is a patient-focused company that inspires and empowers employees to grow through life-changing work. We are a certified Global Top Employer, offering stimulating careers, encouraging innovation, and striving for excellence in everything we do. Our inclusive, collaborative workplace is united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Location

Boston, MA

Benefits

Takeda offers a comprehensive compensation package, including a competitive base salary range of $149,000 - $234,300, as well as 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.



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