Associate Director, Global Regulatory Lead, Oncology

Regulatory Toolkit; Boston (MA); Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking an Associate Director, Global Regulatory Lead Oncology in Boston to define and lead global regulatory strategies for oncology programs and oversee major submissions. You will guide cross-functional teams to bring breakthrough therapies to patients worldwide and serve as the primary FDA contact for your projects.

The role requires 6+ years in pharma regulatory, strong communication skills, and experience with global submissions. The position is hybrid and based in Boston, MA.

Qualifications

• Bachelor’s Degree in a scientific discipline; an advanced degree is strongly preferred.
• 6+ years of pharmaceutical industry experience including regulatory and/or related work.
• Solid working knowledge of drug development and regulatory requirements (FDA, EU, Canada, ROW; post-marketing a plus).
• Experience in reviewing, authoring, or managing components of regulatory submissions is preferred.
• Strong oral and written communication, timeline management, and cross-functional collaboration.

Responsibilities

• Define, develop, and lead global regulatory strategies for oncology programs.
• May lead Global Regulatory Teams (GRTs) for assigned projects.
• Serve as global/regional regulatory lead and primary FDA contact for projects of responsibility.
• Oversee US FDA submissions and approvals.
• Collaborate with Takeda regions to ensure a global regulatory strategy is created and executed.
• Lead regulatory due diligence discussions and interactions with health authorities as applicable.

Skills

Regulatory strategy

FDA knowledge

Regulatory submissions

Cross-functional leadership

Education

Bachelor’s degree (science)

Advanced degree preferred

Job description

Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access to transformative medicines and make a lasting impact on patients worldwide.

Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team. As Associate Director, Global Regulatory Lead Oncology, you will define and lead global regulatory strategies for oncology programs, oversee major submissions, and guide cross-functional teams to bring breakthrough treatments to patients globally.

How you will contribute:

• Define, develop, and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.

• May lead the Global Regulatory Teams (GRTs) for assigned projects.

• May serve as global and/or regional regulatory lead as a member of a GRT

• Primary FDA contact for projects of responsibility.

• Accountable for all US FDA submissions and approvals of project(s) of responsibility.

• May act as direct point of contact with health authorities and lead and manage FDA meetings.

• Define strategies, provide tactical guidance to teams, and collaborate cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.

• For the project(s) of responsibility, collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility.

• Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.

• Participate with influence in or lead departmental and cross-functional task-forces and initiatives.

• May partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.

• May lead regulatory assessment as part of due diligence teams for licensing opportunities.

• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

• Responsible for demonstrating Takeda leadership behaviors.

• Participate with influence in or leads departmental and cross-functional task-forces and initiatives.

Minimum Requirements/Qualifications:

• Bachelor’s Degree required, scientific discipline strongly preferred, advanced degree in a scientific discipline strongly preferred.

• 6+ years pharmaceutical industry, inclusive of regulatory and/or related experience.

• Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.

• Preferred experience in reviewing, authoring, or managing components of regulatory submissions.

• Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.

• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.

• Demonstrate acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

• Must work well with others and within global teams.

• Able to bring working teams together for common objectives.

• Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

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.

This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.

#LI-Hybrid

#LI-AA1

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:

$154,400.00 - $242,550.00

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.

For information about our benefits, please click here.

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.