Director, Regulatory CMC - Cell & Gene Therapy

Vertex Pharmaceuticals Incorporated; Boston, Auburn (MA, ME); Hybrid; USD 189,000 - 285,000; Full time

Job summary

An established industry player is seeking a Director of Regulatory CMC to spearhead global strategies for innovative cell and gene therapy products. This pivotal role involves leading a cross-functional team to ensure compliance with regulatory requirements and overseeing the preparation of submissions to health authorities. The ideal candidate will possess extensive experience in the pharmaceutical sector and a strong understanding of regulatory guidelines. Join a dynamic organization that values scientific innovation and offers a collaborative environment to drive impactful change in healthcare.

Benefits

Medical Benefits

Dental Benefits

Vision Benefits

Paid Time Off

Educational Assistance

Commuting Subsidy

401(k) Plan

Annual Bonus

Equity Awards

Qualifications

• 10+ years in the pharmaceutical or biotech industry.
• 3 years of supervisory experience.
• Strong knowledge of regulatory guidelines.

Responsibilities

• Lead cross-functional team for regulatory CMC strategies.
• Prepare and review CMC sections of regulatory submissions.
• Develop global CMC regulatory strategies.

Skills

Interpersonal Skills

Strategic Thinking

Problem-Solving

Planning and Prioritization

Regulatory Knowledge (FDA, EMA, Health Canada, ICH)

Process Improvement

Influencing Decisions

Education

Bachelor's Degree in Biology

Master's Degree in Chemistry

PhD in Regulatory Affairs

Job description

Job Description

General Summary:

The Director, Regulatory CMC leads a cross-functional team in the execution of global regulatory CMC strategies for investigational and marketed cell and gene therapy products. This role is accountable for the preparation and filing of regulatory CMC submissions and managing the interactions with Health Authorities for CMC topics. This role provides regulatory guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and marketed products.

Key Duties and Responsibilities:

• Oversees the preparation and review of CMC sections of regulatory submissions, and leads the interactions and responses with regulatory agencies
• Leads the development of global CMC regulatory strategies for multiple investigational and/or marketed products
• Leads the design, development and implementation of department strategies and contributes to the strategic planning for the area
• Ensures assigned projects are appropriately resourced and is accountable for the results of the team

Knowledge and Skills:

• Excellent interpersonal skills to influence others internally and/or externally and to negotiate with others in a limited capacity
• Advanced strategic thinking and 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
• Comprehensive knowledge of regulatory (FDA. EMA, Health Canada and ICH) guidelines
• Experience with development and/or improvement of department processes/procedures
• Proven ability to impact and influence the decisions of a team and decision making committees

Education and Experience:

• Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field
• Typically requires 10 years of experience in the pharmaceutical or biotech industry or in a related field and 3 years of supervisory/cross-functional management experience, or the equivalent combination of education and experience

#LI-SV1 #LI-Hybrid

Pay Range:

$189,500 - $284,200

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:
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 Vertex's 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 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 [e-mail]