Associate Director, Global Regulatory Affairs Marketed Products

Job Description

At Takeda, we are a forward‑looking, world‑class R&D organization that unlocks innovation and delivers transformative therapies to patients. We focus R&D efforts on four therapeutic areas and other targeted investments to bring life‑changing therapies globally. As Associate Director, Global Regulatory Affairs for Marketed Products you will lead and contribute global strategies to maximize regulatory success for complex projects.

• Lead and contribute to global strategies that maximize regulatory success toward program objectives for complex and/or multiple projects.
• Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, ensuring compliance with applicable regulatory requirements.
• Serve as a department leader, contributing to cross‑functional Takeda initiatives and influencing the field as applicable.
• Act as global regulatory lead (GRL), responsible for the design and execution of global regulatory strategies in collaboration with regional counterparts.

How You Will Contribute

• Lead the Global Regulatory Team (GRT) and applicable sub‑working groups, such as the Label Working Group, and represent GRT at project team meetings as global and/or regional regulatory lead.
• Define strategies and provide tactical guidance to teams, collaborating cross‑functionally to keep the global regulatory strategy updated and executed in line with changing regulatory and business needs.
• Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating professionally and timely.
• Proactively anticipate risks and develop solutions or scenario planning for identified risks, discussing with team and management; understand probabilities of technical success for the solutions.
• Be accountable for execution of global regulatory strategy, including provision of global regulatory submissions to local Takeda affiliates in compliance with local regulatory requirements, working with regional leads, other functions and vendors. Accountable for US FDA submissions and approvals of projects, leading all submission types.
• Serve as the primary FDA contact, leading and managing FDA meetings.
• Manage junior staff as needed and demonstrate Takeda leadership behaviors.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Participate with influence in departmental and cross‑functional task‑for‑forces and initiatives.
• Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product‑specific value evidence topics, monitoring and anticipating trends that impact both the regulatory and access environments.
• Support the lead regulatory reviewer in due diligence for licensing opportunities.

Minimum Requirements / Qualifications

• BSc Degree (BA accepted).
• 8+ years of pharmaceutical industry experience, including 6 years of regulatory experience or a 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.
• Knowledge of FDA, EU, Canada, ROW and post‑marketing is a plus.
• Ability to understand and interpret complex scientific issues across multiple projects in relation to regulatory requirements and strategy.
• Strong oral and written communication skills, with the ability to manage and adhere to timelines, negotiate, and demonstrate integrity and adaptability.
• Proven regulatory strategy skills, including an understanding of core regulatory concepts and their organizational and global implications.
• Proactive identification of regulatory issues and the proposal of creative, practical solutions and strategies, including risk mitigation.

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, united by an unwavering commitment to deliver better health and a brighter future to people worldwide.

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 strive to be more transparent with our pay practices.

For Location

Boston, MA

U.S. Base Salary Range

$153,600.00 – $241,340.00

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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