Regulatory CMC Manager - Cell & Gene Therapy (Contract)

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

Job summary

Vertex Pharmaceuticals LLC seeks a Regulatory CMC Manager to drive international CMC submissions and regulatory strategies for cell and gene therapy programs. You will collaborate with cross-functional teams to ensure regulatory requirements are integrated throughout the product lifecycle.

The role involves planning, preparing, and submitting CMC documentation, providing guidance on FDA/EMA and international guidelines, and supporting post-approval changes in a global setting.

Qualifications

• Bachelor's degree in life sciences or related field.
• 5+ years of Regulatory CMC experience including cell & gene therapy.
• Proficiency with FDA, EMA and international regulatory guidelines.
• Experience in preparation, reviews and submissions of CMC post-approval variations.

Responsibilities

• Plan and execute international regulatory CMC submissions with content plans and cross-functional alignment.
• Review CMC sections of regulatory submissions and responses with agencies.
• Contribute to global regulatory CMC strategy for commercial products.
• Collaborate with regulatory and technical teams to ensure timely post-approval CMC changes.
• Provide regulatory CMC guidance to cross-functional teams and stakeholders.

Skills

Regulatory CMC leadership

Cell & Gene Therapy

FDA EMA guidelines

Regulatory submissions

Education

Bachelor's degree in Life Sciences or related field

Job description

Job Description

The Chemistry Manufacturing Controls Manager will supportthe 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

No C2C or Third-Party Vendors