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 Operations, Labeling and Compliance – Vaccines Business Unit in our Cambridge, Massachusetts 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.
As a Director, Regulatory Operations, Labeling and Compliance working in the Vaccines Business Unit team, you will be empowered to oversee the compilation and publishing of all regulatory submission types in accordance with Global Regulatory Affairs objectives for both marketed and developmental products, specifically global marketing applications and routine submissions e.g. lifecycle management and PSUR submissions. A typical day will include:
Maintain an expert, current knowledge of regulations, legislation, best practices and guidelines as they relate to global submission management and support and interpret into system or process changes as appropriate.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelor’s degree, preferably in life sciences.
10 + years working within Regulatory and/or Regulatory Operations in the life sciences industry.
2 + years of experience of vendor/alliance management.
Moderate first line management experience.
Major document management and submission publishing experience.
Proven experience in developing and implementing lean and efficient processes.
Experienced in business change management.
Fluent with the drug development process with evidence of working with Regulatory Agencies supporting regulatory dossier submission, review and approval processes.
Significant experience multitasking in a deadline controlled, complex and highly regulated environment.
Experience introducing new systems and procedures based on interpretation and application of regulatory agency guidance documents and mandated legislation such as eCTD.
Ability to apply knowledge to new situations. Strong communication skills. Demonstrated ability to present and articulate requirements and adjust to project needs.
This job posting excludes Colorado applicants.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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
Learn more at takedajobs.com
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.