Regulatory CMC Manager

Vertex Pharmaceuticals LLC; United States; Remote; USD 103,000 - 110,000; Full time

Job summary

Vertex Pharmaceuticals in the United States is seeking a Regulatory CMC Manager to support multi-product global regulatory CMC activities for marketed products, with a focus on Biologics and regulatory submissions.

The role contributes to the preparation and submission of regulatory CMC documentation, reviews CMC sections of submissions, collaborates with FDA/EMA/Health Canada teams, and serves as a primary CMC contact for assigned products and projects, ensuring timely, compliant deliverables.

Qualifications

• Bachelor's degree in a life-science field (Biology, Chemistry, Pharmacy, Regulatory Affairs, Biologics or Medical Devices).
• Typically requires 4 years of pharmaceutical industry experience or equivalent combination of education and experience.

Responsibilities

• Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU.
• Review CMC sections of regulatory submissions and manage agency interactions.
• Collaborate on global regulatory CMC strategies and submissions.
• May serve as the primary regulatory CMC contact for assigned products and projects.

Skills

Regulatory guidelines

Cross-functional communication

cGMP knowledge

Problem-solving

Prioritization

Education

Bachelor's degree in life sciences/related field

Job description

Job Description

Regulatory CMC ManagerGeneral Position SummaryThe Chemistry Manufacturing Controls Manager will support the execution of multi-product global regulatory CMC for marketed products. This role contributes to the preparation and submission of regulatory CMC documentation including clinical trial submissions and provides regulatory support to various cross functional teams with a focus on Biologics.

Key Duties and Responsibilities

• Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU.
• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.
• Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions.
• Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects.

Required Education Level & Experience

• Bachelor's degree, with a preference 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.

Required Knowledge/Skills

• Strong interpersonal skills to exchange complex information with others and to guide others.
• Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines.
• 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.
• Sound knowledge of cGMP, FDA, EMA, ICH.

Pay Range

$75-$80/HR

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements