Remote Regulatory CMC Manager – Cell & Gene Therapy

Vertex Pharmaceuticals LLC; 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

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.