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 Senior Associate, Global Regulatory Affairs CMC - Submission Management in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Associate working on the Submission Management team, you will be empowered to support the Global Regulatory CMC Lead in preparation of development submissions (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA) and Post-Approval Changes, and a typical day will include:
- With supervision, supports the execution of regulatory CMC investigational, registration and post-approval strategies for assigned products. Supports Regulatory teams for assigned products throughout clinical development and commercial lifecycle.
- Develops a solid understanding of global RA CMC regulations and guidelines, and participates in the development of strategies to enhance probability of regulatory success or enhancing regulatory compliance.
- Interacts and effectively communicates with other internal and external colleagues.
- With supervision, executes regulatory submissions for assigned projects.
- Helps define CMC content (data and documentation) requirements for regulatory submissions.
- With supervision, participates in Health Authority interactions and supports preparation activities for meetings with Health Authorities on CMC related matters.
- Ensures line management is apprised of developments that may impact regulatory success, communicating in a professional and timely manner.
- Evaluates change proposals for global regulatory impact with supervision and may support planning of variations and amendments.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education and Experience Required:
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 2 yrs work experience in a supportive role; experience with pharmaceuticals or equivalent industry experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance) is valuable.
- Familiarity with global regulatory guidelines and experience in regulatory submission (CMC Module 3 information and QOS documents) is valuable
- Demonstrates attention to detail and problem-solving abilities.
- Excellent written and oral communication skills required.
- Experience working with cross-functional teams (or an equivalent), preparation of high quality documents (i.e., for submissions), and an ability to execute on activities
- Routine demands of an office based environment.
- Manual dexterity required to operate office equipment (ie computers, phones, etc)
- Ability to attend offsite meetings that may involve overnight stay
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
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.