Manager, Regulatory Lead

at  Takeda Pharmaceutical

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MINIMUM REQUIREMENTS/QUALIFICATIONS:

• BSc degree preferred and advanced degree a plus. BA accepted
• Minimum of 2 years of pharmaceutical industry experience, with a minimum of 1 years of within a regulatory strategy role
• Plasma or biologics experience preferred
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions
• Knowledge of global regulatory requirements and prior FDA interactions/submissions experience
• Ability to use precedent and previous experience to develop innovative/flexible approaches to achieve commercial goals
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Demonstrate skills and ability to work well in a matrixed environment to deliver on tactics.

MORE ABOUT US:

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

TAKEDA COMPENSATION AND BENEFITS SUMMARY

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. As Manager Regulatory Lead you will be accountable for recommending and implementing regulatory strategy and coordinating life cycle activities across the portfolio of PDT products.