Global Regulatory Lead, GI and Inflammation Director
hace 2 semanas
About the Role:
Takeda is 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.
We are seeking an Associate Director, Global Regulatory Lead, GI & Inflammation to define, develop, and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
Key Responsibilities:
- Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
- Lead the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represent GRTs at project team meetings.
- Define strategies and provide tactical guidance to teams and collaborate cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance.
- Serve as global and/or regional regulatory lead as a member of a GRT.
- Anticipate risks and develop solutions to identified risks and discussing with team and management.
Requirements:
- Bachelor's Degree, scientific discipline strongly preferred.
- Advanced degree in a scientific discipline (PhD/PhD/MD) strongly preferred.
- 6+ years of pharmaceutical industry experience, including 4 years of regulatory experience or combination of 6+ years regulatory and/or related experience.
- Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
About Takeda:
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.
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Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use.I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
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Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoJob Description About the role: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...
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Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
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Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
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