Global Regulatory Strategist, GI
2 days ago
We are a patient-focused company that strives for excellence in everything we do. At Takeda Pharmaceutical, we unlock innovation and deliver transformative therapies to patients worldwide.
About the RoleAs a Senior Director, Global Regulatory Lead, GI & Inflammation, you will define, develop, and lead global strategies to maximize regulatory success towards achievement of program objectives for complex projects.
- You will provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
- You are a key leader within the department and R&D, leading cross-functional initiatives and influencing the field as applicable.
- You will provide leadership and development for direct reports, including those responsible for designing and executing global regulatory strategies in collaboration with regional counterparts.
As a Senior Director, you will be responsible for defining strategies and providing tactical guidance to teams to ensure global regulatory compliance. You will collaborate cross-functionally to update and execute the global regulatory strategy, anticipating changing regulatory and business needs.
You will ensure project team colleagues, line management, and stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and professional communication.
You will proactively anticipate risks and develop solutions, understanding probabilities of technical success for proposed solutions.
You will oversee all US FDA submissions and approvals, managing direct reports or junior staff as needed.
You will be the direct point of contact with health authorities, leading and managing FDA meetings and other regional HA meetings.
You will work with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions comply with local regulations.
You will participate in departmental and cross-functional task-forces and initiatives, leading regulatory reviewer due diligence for licensing opportunities.
RequirementsTo succeed in this role, you must have:
- A Bachelor's Degree, scientific discipline preferred
- Advanced degree in a scientific discipline (Ph.D./PharmD/MD) strongly preferred
- 10+ years of pharmaceutical industry experience, inclusive of 8 years of regulatory experience or combination of 6+ years regulatory and/or related experience
- Expert knowledge of drug development process and regulatory requirements
- Strong oral and written communications, managing timelines, negotiation skills, integrity, and adaptability
We foster an inclusive, collaborative workplace where our teams are united by an unwavering commitment to delivering Better Health and a Brighter Future to people around the world.
This position is classified as hybrid in accordance with Takeda's Hybrid and Remote Work policy.
CompensationThe estimated salary range for this position is $205,100 - $322,300 per year, based on location and qualifications.
Takeda offers competitive compensation, benefits, and career growth opportunities.
We are committed to equitable pay for all employees and strive to be transparent with our pay practices.
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