Regulatory CMC Manager

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

Job summary

Vertex Pharmaceuticals in Boston seeks a Regulatory CMC Manager to support multi-product regulatory CMC for marketed products, including preparation and submission of CMC documentation for clinical trials and cross-functional regulatory support with a biologics focus.

The role requires a biology/chemistry/Regulatory Affairs background with 4 years of pharma experience and strong knowledge of FDA, EMA, and ICH guidelines. Collaboration and planning are essential in a fast-paced environment.

Qualifications

• Bachelor's degree in biology, chemistry, pharmacy, regulatory affairs or related life-science field.
• Typically requires 4 years of pharma industry experience or equivalent.
• Strong interpersonal and regulatory guidelines knowledge.
• Ability to collaborate and communicate clearly across teams.
• Sound knowledge of cGMP, FDA, EMA and ICH.

Responsibilities

• Execute lifecycle management strategy for CMC submissions focusing on US/CA/EU.
• Review CMC sections of regulatory submissions and agency interactions.
• Develop global regulatory CMC strategies and submissions.
• Serve as the primary regulatory CMC contact for assigned products and projects.

Skills

Regulatory guidelines

Interpersonal skills

cGMP knowledge

Cross-functional collaboration

Planning

Problem solving

Education

Bachelor's degree in life sciences

Tools

Regulatory submissions software

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

No C2C or Third-Party Vendors