Title: Senior Manager, Regulatory CMC, Cell & Gene Therapy
Location: Boston United States
Full time
Job Description:
Job Description
General Summary:
The Chemistry Manufacturing Controls Senior Manager will participate in the execution of multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and submission of regulatory CMC documentation. This role also acts as a resource for regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs.
Key Duties and Responsibilities:
Prepares and reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
Develops global regulatory CMC strategies for investigational and/or commercial products
Collaborates with regulatory colleagues in development of global regulatory CMC strategies and submissions
Provides regulatory CMC guidance in complex situations to cross-functional teams and key stakeholders
Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Collaborates effectively on cross -functional teams and acts as the primary regulatory CMC contact for assigned products and projects
Knowledge and Skills:
Proficiency in effective interpersonal skills to explain difficult information and build consensus
Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
Proficiency in leading the preparation, including writing, of CMC submissions
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
Capable of strategic thinking with ability to resolve complex and ambiguous situations
In-depth knowledge of cGMP, FDA, EMA, and ICH
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 6 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience
LI-EE1 #LI-Hybrid
Pay Range:
$140,200 - $210,300
Disclosure 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 Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or select
On-Site: work five days per week on-site with ad hoc flexibility.
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.
