Manager, Global Regulatory Affairs - GI

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description
About the role:

Manager, Global Regulatory Affairs – GI

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.  Join us as a Manager, Global Regulatory Affairs – GI, based in Cambridge, MA.

Leads global regulatory team to develop strategies to maximize regulatory success towards achievement of program objectives with supervision as appropriate.
Provides regulatory strategic and tactical advice to teams with focus on non-clinical and clinical aspects of drug development to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.

How you will contribute:

ACCOUNTABILITIES
Responsible for managing one or more projects with less complexity. May support GRL on more complex programs. May lead the Global Regulatory Team (GRT), and applicable sub-working groups and represents GRT at project team meetings.
Responsible for achieving submission of INDs, CTAs, briefing packages, responses, and other submissions. Major submissions (NDA/BLA/MAA) under oversight of manager.
Provides strategic and tactical guidance to teams, including regulatory review of clinical trial documents and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance.
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 and to maintain compliance for products.
Ensures project team colleagues, line management, and key statkeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
May develop/author or assist Global Regulatory Lead with development of global regulatory strategy.
Assists and attends FDA and other agency meetings.
Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
May participate on departmental task-forces or initiatives.

Minimum Requirements/Qualifications:
BSc Degree preferred.  BA accepted.
A minimum of 4 years of pharmaceutical industry experience.  This is inclusive of 3 years of regulatory experience or combination of 2 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.
Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects.
Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
Demonstrates 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.

What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Flexible Work Paths
Tuition reimbursement

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.

LOCATION:
The role can be hybrid or at our Cambridge, MA office

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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