Regulatory CMC Manager - Cell & Gene Therapy (Contract)

Vertex Pharmaceuticals; United States; Remote; USD 96,000 - 110,000; Full time

Job summary

Vertex Pharmaceuticals LLC is seeking a Regulatory CMC Manager to support international regulatory CMC strategies for cell and gene therapy products. The role involves planning, preparing and submitting regulatory CMC documentation, and guiding cross-functional teams on applicable regulatory requirements throughout product lifecycles.

Responsibilities include developing global CMC strategies, managing post-approval changes, and coordinating with regulatory agencies to ensure timely approvals.

Qualifications

• Strong interpersonal skills for complex information exchange and guiding others.
• Proficiency in FDA, EMA and international regulatory guidelines.
• Experience in preparation, reviews and submissions of CMC post-approval variations.
• Strategic thinking and ability to resolve complex situations.
• Ability to collaborate and communicate clearly and timely with stakeholders.
• Experience in cell & gene therapy regulatory CMC is preferred.

Responsibilities

• Planning and execution of international regulatory CMC submissions with cross-functional alignment.
• Review CMC sections of regulatory submissions and manage agency interactions.
• Contribute to global regulatory CMC strategies for commercial products.
• Ensure timely submission and approval of CMC changes post-approval.
• Provide regulatory CMC guidance to cross-functional teams and stakeholders.
• Support assessment of product compliance topics including change controls, deviations, and GMP investigations.

Skills

Interpersonal skills

Regulatory CMC knowledge

FDA/EMA guidelines proficiency

CMC submissions experience

Strategic planning

Cross-functional collaboration

Problem-solving

Education

Bachelor's degree in life sciences or related field

Job description

Job Description

The Chemistry Manufacturing Controls Manager will support the execution of cell and gene therapy regulatory CMC strategies for marketed products. This role contributes to the planning, preparation and submission of regulatory CMC documentation. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable international regulatory requirements are considered and appropriately incorporated into the lifecycle of cell and gene therapy programs.

Key Duties & Responsibilities

• Planning and execution of international regulatory CMC submissions, including creation of content plans and ensuring cross functional alignment
• Reviews 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 commercial products
• Works with regulatory and technical colleagues to ensure timely submission and approval of CMC changes in the post approval environment
• Provides regulatory CMC guidance to cross-functional teams and key stakeholders
• Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

Required Education Level & Experience

• Strong interpersonal skills to exchange complex information with others and to guide others
• Proficiency in FDA, EMA and international regulatory guidelines
• Experience in the preparation, reviews and submissions of CMC post approval variations
• Strong sense of planning, strategic thinking and problem-solving skills
• Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
• Capable of strategic thinking with ability to resolve complex and ambiguous situations
• Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
• 5 years of Regulatory CMC experience, including Cell & Gene Therapy Regulatory CMC experience.

Contract length: 12 months with the chance to extend.

Pay Range: $70/hr. - $80/hr.

Shift/Hours: Monday-Friday; Remote: EST hours

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