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 an Associate Director, GRA CMC Biologics in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, GRA CMC Biologics working on the Global Regulatory Affairs team, you will be empowered to strategic and innovative, and a typical day will include:
Participates in the development of regulatory CMC development and registration strategies as the RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams for assigned products throughout clinical development and commercial lifecycle. Ensures global strategies are successfully executed across both new product development and existing portfolio life cycle management.
Interfaces cross-functionally both within the regulatory affairs team as well as with commercial, clinical development, global marketing, quality, etc to ensure that data are identified, obtained and effectively presented for the registration of products world-wide.
Independently plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities
Ensures 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
Develops and maintains constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Takeda, Alliance Partners, and Health Authority representatives
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
8 + years pharmaceutical Regulatory CMC experience. Alternatively 5+ years pharmaceutical Regulatory CMC experience combined with 3+ years relevant pharmaceutical experience (e.g. Pharmaceutical Development, Pharmaceutical Sciences, Analytical Development, Production, Quality Assurance)
Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required.
- RAC certification desirable but not mandatory
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 an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.