Regulatory CMC Manager

Atrium; Boston (MA); On-site; USD 103,000 - 110,000; Full time

Job summary

Vertex Pharmaceuticals is seeking a CMC Manager to support multi-product regulatory CMC activities for marketed biologics and drugs. The role emphasizes preparation and submission of CMC documentation and cross-functional regulatory support.

You will lead US/CA/EU lifecycle submissions, review CMC sections and agency interactions, and work with development teams to shape global CMC strategies and responses.

Qualifications

• Bachelor's degree in life sciences or related field.
• Typically 4 years of pharmaceutical industry experience or equivalent.
• Experience with regulatory (FDA/EMA/Health Canada/ICH) guidelines preferred.

Responsibilities

• Execute lifecycle management (LCM) strategies and submissions focusing on US/CA/EU.
• Review CMC sections of regulatory submissions and agency communications.
• Collaborate with regulatory teams to develop global CMC strategies and submissions.
• May serve as the primary regulatory CMC contact for assigned products/projects.

Skills

Interpersonal skills

Regulatory guidelines

Problem solving

Collaboration & communication

Planning & prioritization

cGMP knowledge

Education

Bachelor's degree in life sciences

Job description

The 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