Device Regulatory CMC - Manager (Contract) 793

Vertex Pharmaceuticals; United States; On-site; USD 103,000 - 110,000; Full time

Job summary

Vertex Pharmaceuticals in the United States is seeking a Chemistry Manufacturing Controls Manager – Device to lead global regulatory CMC strategies for drug-device combinations and support submissions across development and commercial programs.

You will collaborate with device development, quality, clinical development, human factors, and analytical teams, and may serve as the primary regulatory CMC contact for assigned products and projects, ensuring compliance with FDA, EMA, and ISO standards.

Qualifications

• Bachelor's degree in life-science field or related engineering
• Typically 4 years of experience in medical device/pharma industry or equivalent
• Experience supporting regulatory submissions/filings for combination products
• Experience supporting Human Factors studies for devices and combination products
• Preferred experience with infusion systems/devices for drugs/cell therapies

Responsibilities

• Reviews CMC sections of regulatory submissions in support of development and commercial device programs
• Contributes to development of global regulatory CMC strategies for commercial drug-device products
• Participates on cross-functional teams and may serve as primary regulatory CMC contact for assigned products
• Reviews device development documentation to support design controls for drug-device products
• Supports regulatory assessment and guidance on product compliance topics including change controls and process improvement

Skills

Interpersonal skills

Regulatory knowledge

Regulatory guidelines

Problem solving

Communication

Planning & prioritization

Cross-functional collaboration

Education

Bachelor's degree in life sciences or engineering

Job description

Job Description The Chemistry Manufacturing Controls Manager – Device will support the execution of global regulatory CMC strategies for marketed and development drug-device combination products. This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs.

Key Duties and Responsibilities

• Reviews CMC sections of regulatory submissions in support of development and commercial device programs
• Contributes to the development of global regulatory CMC strategies for commercial drug-device combination products
• Participates effectively on cross-functional teams (including device product development, quality, clinical development, human factors, analytical development, marketing) and may serve as the primary regulatory CMC contact for assigned products and projects
• Reviews device development documentation as needed to support design controls of drug-device combination products
• Supports regulatory assessment and guidance on product compliance topics including change controls and process improvement

Required Education Level & Experience

Bachelor's degree, with a preference in Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, Pharmacy, Regulatory Affairs, or another related life-science field

Typically requires 4 years of experience in the medical device, pharmaceutical industry or related field, or the equivalent combination of education and experience

Experience supporting regulatory submissions/filings for combination products, including autoinjectors, pre-filled pens, and/or pre-filled syringes

Experience supporting Human Factors studies for devices and combination products

Preferred experience with infusion systems/devices for drugs/cell therapies

Required Knowledge/Skills

• Strong interpersonal skills to exchange complex information with others and to guide others
• Knowledge of combination product and device regulatory requirements (FDA, EU MDR, GSPRs)
• Proficiency in regulatory (FDA, Notified Body, MDCG, EMA, ISO, etc.) guidelines
• Strong problem-solving skills
• Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
• Strong sense of planning and prioritization, and the ability to work with all levels of management
• Sound knowledge of Design Controls, cGMP, FDA, EMA, ISO Standards (ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, ISO 11040, etc.)

Pay Range $75-$80/hr