Director - Bellerose | Zoek USA | 000d7d
This Browser does not support all the features of .
For the best experience please use a Modern Browser.
Director , Regulatory Affairs Vaccines-Remote Eastern USA
Permanent (Full time)
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a, Director Regulatory Affairs Vaccines (Open) in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
- Work with the Global Regulatory Lead to develop and execute regulatory strategy for assigned vaccine projects, and potentially serves as the Regulatory Lead on a Global Project Team; a proven regulatory strategist with strong knowledge of regulatory affairs for vaccines.
- Provides regulatory oversight for assigned projects, focused on non-clinical and clinical aspects of drug development and associated regulations.
- Collaborates with all Takeda regional and CMC counterparts to ensure a global regulatory strategy is created and executed upon for all projects within therapeutic area of responsibility.
- Has a passion for quality in all areas of responsibility.
- Authors and ensures global regulatory strategies are developed and accurately reflected in the RFP (Regulatory Functional Plan). Works closely with Regulatory Affairs Vaccines (RAV) Regional Regulatory Heads and CMC-RA to develop global strategy.
- Oversees and accountable for Health Authority submissions and approvals within area of responsibility. Has a quality focus so that submissions are right-first-time.
- Oversees and accountable for ensuring dossiers are submitted on schedule by local Takeda affiliates, as applicable, within area of responsibility by ensuring the regulatory deliverables are provided as outlined in the RFP.
- In collaboration with RAV Regional Regulatory Heads and /or the Global Head of RAV CMC, works to resolve regional critical conflicts in global regulatory strategies and oversee critical deliverables to all territories as agreed within the global regulatory strategy.
- Leads and manages Health Authority meetings, as applicable.
- Leads regulatory review in due diligence for licensing opportunities, as assigned.
- Manages resources (internal or external) to meet program demands. Elevates needs when necessary.
- Identifies regulatory requirements and trends across therapeutic area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
- Uses excellent judgment when making decisions; escalates issues / decisions as appropriate.
- Other duties as needed
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS, advanced scientific degree preferred.
- A minimum of 10 years of pharmaceutical industry experience. This is inclusive of 8 years of regulatory experience or combination of 10 years regulatory and/or related experience in the vaccine area.
- Preferred experience in managing multiple filings resulting in first-time approval; or managing multiple programs in closely related development area; global experience necessary.
- Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as the issues relate to regulatory requirements and strategy.
- Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Must be strong overall and able to proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Exceptionally strong in the following areas: working well with others including on global teams, global-mindset, and communication with senior leadership.
- Must be a strong leader that creates a regulatory vision for the GPT. Inspires and motivates. Takes stand on important issues in productive, respectful way.
- Manual dexterity to operate office equipment (. computers, phones, etc.)
- 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:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- 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
Empowering Our People to Shine
Discover more at
No Phone Calls or Recruiters Please.
This job posting excludes CO applicants.
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.