Hybrid CMC Regulatory Affairs Associate Director

Vertex Inc.; Boston (MA); Hybrid; USD 166,000 - 250,000; Full time

Job summary

Vertex is seeking a Chemistry Manufacturing Controls Associate Director to lead multi-product global CMC strategies and oversee submissions for investigational and marketed products. The role interfaces with Health Authorities and cross-functional teams, providing regulatory guidance and supervision of staff where needed.

The position supports hybrid or on-site work arrangements, with a focus on ensuring global regulatory compliance, change controls, deviations, and GMP investigations across

Qualifications

• Bachelor’s degree in a life-science field.
• About 8 years of pharmaceutical/biotech experience or equivalent.
• Strong knowledge of global regulatory CMC guidelines.

Responsibilities

• Leads preparation and review of CMC sections of regulatory submissions.
• Develops global CMC regulatory strategies for multiple products.
• Guides cross-functional teams on global CMC regulatory topics.
• Interacts with regulatory agencies and coordinates responses.
• Mentors regulatory staff and oversees project execution.

Skills

Interpersonal skills

Strategic thinking

Cross-functional collaboration

Planning and prioritization

Regulatory guidelines (FDA/EMA/ICH)

Regulatory strategy leadership

Global regulatory submissions

Education

Bachelor’s Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field

Typically requires 8 years of experience in pharma/biotech or related field

Job description

Vertex is seeking a Chemistry Manufacturing Controls Associate Director to lead multi-product global CMC strategies and oversee submissions for investigational and marketed products. The role interfaces with Health Authorities and cross-functional teams, providing regulatory guidance and supervision of staff where needed.

The position supports hybrid or on-site work arrangements, with a focus on ensuring global regulatory compliance, change controls, deviations, and GMP investigations across