Manager, Regulatory Lead

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Job Description

About the role:

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.

How you will contribute:

• Serves as the regulatory lead for one or more projects and coordinates the Global Regulatory Team (GRT) meetings composed of core regulatory support functions.

• Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of plasma derived therapies, while ensuring compliance with applicable regulatory requirements.

• Liaises with the US FDA on submissions within their responsibilities.

• Serves as the lead interface between PDT global regulatory affairs, global subject matter experts, international LOCs, EU & Canada strategy, Japan and China, to facilitate the collection of regulatory documentation for new registrations and license maintenance.

• Assists in  the creation and execution of global regulatory strategies for assigned programs and ensures the global regulatory strategies for assigned programs are up-to-date.

• Collaborates with EU & Canada, Japan, China and/or other regional counterparts in compiling global regulatory strategies and works cross-functionally with RA and R&D program team members to ensure critical deliverables to countries/regions outside the US are achieved and timely execution of the strategy is met.

• Supports global regulatory subteam (GRT) and, cross-functional subteams and working group to execute regulatory submissions. Assists in the creation and submission of high quality, compliant regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as PIPs/PSPs, ODDs, meeting requests and briefing packages) for assigned programs within defined timelines as per R&D and business objectives.

• Responsible for regulatory submissions for assigned programs. Works cross-functionally with RA and R&D program team members to ensure critical deliverables to countries/regions outside the US are achieved and timely execution of the strategy is met.

• Assists with FDA health authority interactions/meetings related to assigned programs and supports regional and local regulatory affairs teams with health authority interactions.

• Identifies and notifies management of any resource gaps for project responsibility. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with the assigned team and management; understands probabilities of technical success for the solutions.

• Ensures accurate, up-to-date reporting of program status and milestones globally through the InterACT system and regulatory dashboard and leverages the Dragonfly visualization tool to highlight any major discrepancies for assigned programs.

• Collaborates with LOCs to identify the documents required for submissions, identifies responsible PDT subject matter experts and facilities alignment on deliverables and timelines.

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. 

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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Job Exempt