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Director, Global Regulatory Lead, GI and Inflammation
2 months ago
Takeda is a patient-focused company that develops novel specialty pharmaceuticals and best-in-class patient support programs. We are seeking a highly skilled Global Regulatory Affairs Director to join our team in Boston, MA.
About the Role:
The Global Regulatory Affairs Director, GI and Inflammation will be responsible for defining, developing, and leading global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. This role 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.
Key Responsibilities:
- Provide leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.
- Lead the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings.
- Define strategies and provide tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance.
- Ensure global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs.
- Proactively anticipate risks and responsible for developing solutions to identified risks and discussing with team and management.
- Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible.
- Direct point of contact with health authorities, leads and manages FDA meetings.
- Accountable for working with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations.
Requirements:
- Bachelor's Degree, scientific discipline strongly preferred.
- Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred.
- 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 4+ years regulatory and/or related experience.
- Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
- Working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW, and post-marketing a plus.
- Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
About Takeda:
Takeda is a patient-focused company that transforms patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are a global top employer and offer stimulating careers, encourage innovation, and strive 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.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
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.
For Location:
Boston, MA
U.S. Base Salary Range:
$169, $266,200.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-term incentives. Employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
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.
