Associate Director, CMC Regulatory Affairs, Biologics (Boston, MA)
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Monthly Salary:
Posted on:
05-09-2025
Vacancies:
1 Vacancy
Job Summary
Job Description
General Summary:
The Associate Director CMC Regulatory Affairs Biologics executes multi-product global regulatory CMC strategies for investigational and marketed products with a focus on biologics. 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 or mentor 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 including lifecycle management for combination biologic drug 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
- Strong knowledge and experience in biologics including BLA and lifecycle management experience
Education and Experience:
- Bachelors 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
#LI-EE1 #LI-Hybrid
Pay Range:
$161400 - $242100Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors including skills competencies experience and other job-related factors permitted by law.
At Vertex our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career financial family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter) educational assistance programs including student loan repayment a generous commuting subsidy matching charitable donations 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:
In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.
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 persons 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
Required Experience:
Director
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Vertex Pharmaceuticals invests in scientific innovation to create transformative medicines for people with serious diseases.
