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Associate Director, Regulatory CMC, Cell Therapy Combination Product (Boston)

Semma Therapeutics

Semma Therapeutics

Product, Legal
Boston, MA, USA
Posted on Tuesday, April 2, 2024

Job Description

General Summary:

The Associate Director, Regulatory CMC executes multi-product global regulatory CMC strategies for cell therapy combination investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages the interactions with Health Authorities for CMC topics. This role also provides regulatory guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial products. This role may supervise other regulatory staff.

Key Duties and Responsibilities:

  • Leads the preparation and review of CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
  • Develops global CMC regulatory strategies for one or more investigational and/or marketed products
  • Leads regulatory colleagues in development of global CMC regulatory strategies and submissions
  • Provides CMC regulatory guidance to cross-functional teams and key stakeholders
  • Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
  • Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects
  • Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise

Knowledge and Skills:

  • Excellent interpersonal skills to communicate difficult concepts and persuade others
  • Strategic thinking and strong problem solving skills
  • Collaborates and communicates in an open, clear, complete, timely, and consistent manner
  • Strong sense of planning and prioritization, and the ability to work with all levels of management
  • Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines
  • Experience with medical devices, specifically combination products is a plus.

Education and Experience:

  • Bachelor's Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field
  • Typically requires 8 years of experience in the pharmaceutical or biotech industry or in a related field, or the equivalent combination of education and experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:

1. Hybrid and work remotely up to two days per week; or select

2. On-Site and work 5 days per week with ad hoc flexibility.

#LI-EE1 #LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.