Regulatory Affairs Chemistry Manufacturing Controls Manager

Vertex; Boston (MA); Hybrid; USD 122,000 - 184,000; Full time

Job summary

A leading biotechnology company is seeking a Regulatory Affairs CMC Manager to oversee global regulatory strategies for investigational and marketed products. The role involves managing product life cycles, preparing regulatory documentation, and collaborating with cross-functional teams to ensure compliance with global regulations. Candidates should possess strong interpersonal and strategic thinking skills, along with a relevant bachelor's degree and experience in the pharmaceutical industry.

Benefits

Medical Benefits

Dental Benefits

Vision Benefits

Generous Paid Time Off

Educational Assistance Programs

Student Loan Repayment

Commuting Subsidy

401(k) Matching

Qualifications

• Typically requires 4 years of experience in the pharmaceutical industry.
• Experience in the preparation of CMC submissions.

Responsibilities

• Lead team to author, review and approve CMC sections of regulatory submissions.
• Contributes to the development of global regulatory CMC strategies.
• Provides regulatory CMC guidance to cross-functional teams.

Skills

Interpersonal Skills

Strategic Thinking

Problem Solving

Collaboration

Education

Bachelor's degree in Biology

Bachelor's degree in Chemistry

Bachelor's degree in Pharmacy

Bachelor's degree in Regulatory Affairs

Tools

Veeva Vault Regulatory Information Management System

Job description

Job Description

General Summary:

The Regulatory Affairs Chemistry Manufacturing Controls (CMC) Manager will influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products. The scope of this role includes leading and managing a specific product's life cycle including post approval variations and line extensions within approved markets and global expansion in new markets. This role contributes to the preparation and submission of regulatory CMC documentation and interactions with Health Authorities for CMC topics. This role also provides regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated intothe life cycle of investigational and commercial programs.

Key Duties and Responsibilities:

• Lead team to author, review and approve CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Contributes to the development of global regulatory CMC strategies for investigational and/or commercial products
• Provides regulatory CMC guidance to cross-functional teams and key stakeholders
• Influences regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
• Participates effectively on cross-functional teams and serve as the global regulatory CMC lead for assigned products and projects

Knowledge and Skills:

• Strong interpersonal skills to exchange complex information with others and to guide others
• Proficiency in global regulatory guidelines (FDA, EMA, Health Canada and ICH)
• Experience in the preparation, including writing, of CMC submissions
• Strategic thinking and strong problem solving skills
• Ability to collaborate and communicate 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
• Sound knowledge of cGMP, FDA, EMA, ICH
• Experience using the Veeva Vault Regulatory Information Management System (RIM)

Education and Experience:

• Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
• Typically requires 4 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience

Pay Range:
$122,600 - $183,900

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]