Remote Regulatory CMC Manager — Small Molecule Drugs

Vertex Pharmaceuticals; United States; Remote; USD 96,432 - 110,208; Full time

Job summary

Vertex Pharmaceuticals seeks a Regulatory CMC Manager to lead detailed planning and execution of multi-product programs in international regions. The role supports regulatory CMC submissions and provides cross-functional regulatory guidance.

Key duties include managing lifecycle activities, planning submissions, and ensuring alignment with global regulatory expectations. The ideal candidate has a life sciences degree and about five years in pharma, with Small Molecule experience and strong

Qualifications

• Bachelor’s degree in life sciences or related field.
• Typically 5 years of pharmaceutical industry experience.
• Experience supporting Small Molecule programs.

Responsibilities

• Execute lifecycle management (LCM) strategy and submissions for marketed products in international regions.
• Plan and execute international regulatory CMC submissions with content plans and cross-functional alignment.
• Review CMC sections of regulatory submissions and respond to regulatory interactions.
• Collaborate on global regulatory CMC strategies and submissions with regulatory colleagues.
• Serve as primary regulatory CMC contact for assigned products and projects within cross-functional teams.
• Support regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.

Skills

Interpersonal skills

Regulatory knowledge

Problem solving

Cross-functional collaboration

Planning and prioritization

Education

Bachelor's degree in life sciences

Job description

Vertex Pharmaceuticals seeks a Regulatory CMC Manager to lead detailed planning and execution of multi-product programs in international regions. The role supports regulatory CMC submissions and provides cross-functional regulatory guidance.

Key duties include managing lifecycle activities, planning submissions, and ensuring alignment with global regulatory expectations. The ideal candidate has a life sciences degree and about five years in pharma, with Small Molecule experience and strong