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Manager, Global Regulatory Affairs - GI
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.
Join Takeda as a Manager, Global Regulatory Affairs - GI where you will lead the global regulatory team to develop strategies to maximize regulatory success towards achievement of program objectives with supervision as appropriate. As part of the Global Regulatory Affairs team, you will report to the Director and provide 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:
Manage 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.
Achieve submission of INDs, CTAs, briefing packages, responses, and other submissions. Major submissions (NDA/BLA/MAA) under oversight of manager.
Provide 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.
Work 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.
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.
May develop/author or assist Global Regulatory Lead with development of global regulatory strategy.
Assist and attend 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.
What you bring to Takeda:
BSc Degree preferred. BA accepted.
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.
Experience in reviewing, authoring, or managing components of regulatory submissions.
Working knowledge of drug development process and regulatory requirements.
Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects.
Demonstrate acceptable skills in 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.
Willingness to travel to various meetings or client sites including overnight trips. Some international travel may be required.
Requires approximately 10 % travel.
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
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.
Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
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.