Device Regulatory CMC - Manager (Contract) 323232

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

Job summary

Vertex Pharmaceuticals LLC in the United States seeks a Chemistry Manufacturing Controls Manager – Device to lead regulatory CMC strategies for drug-device combination products. You will support regulatory submissions and provide guidance to cross-functional teams to ensure global requirements are incorporated.

The role requires a Bachelor's degree in a life-science field and typically 4+ years in pharma or medical devices, with experience in submissions and human factors.

Qualifications

• Bachelor's degree in a life-science field.
• Typically 4+ years in medical device or pharmaceutical industries.
• Experience supporting regulatory submissions for combination products.
• Experience with Human Factors studies for devices.
• Preferred infusion systems/devices experience.

Responsibilities

• Reviews CMC sections of regulatory submissions for development and commercial devices.
• Contributes to global regulatory CMC strategies for combo products.
• Participates on cross-functional teams and may serve as primary CMC contact.
• Reviews device development documentation to support design controls.
• Supports regulatory assessment on change controls and process improvements.

Skills

CMC regulatory

Cross-functional comms

Regulatory knowledge

Design Controls

Submissions experience

Problem solving

Planning & prioritization

Education

Bachelor’s degree

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