Regulatory CMC Manager - Small Molecule (Contract)

Vertex Pharmaceuticals LLC; United States; À distance; USD 96 000 - 110 000; Plein temps

Résumé du poste

Vertex Pharmaceuticals LLC is seeking a Chemistry Manufacturing Controls Manager to lead planning, preparation, and execution of a multi-product program in the international region. The role supports regulatory CMC documentation and cross-functional teams in regulatory activities.

Key duties include managing lifecycle strategy and submissions, coordinating content plans, and ensuring alignment with global regulatory CMC strategies. Remote EST hours and a 12-month contract are offered.

Qualifications

• Bachelor's degree in biology, chemistry, regulatory affairs or related life-science field.
• Typically requires 5 years of pharmaceutical industry experience.
• Experience supporting small molecule programs is required.

Responsabilités

• Execute lifecycle management strategy and submissions for marketed products in international regions.
• Plan and execute international regulatory CMC submissions with cross-functional alignment.
• Review CMC sections of regulatory submissions and manage agency interactions.
• Collaborate on global regulatory CMC strategies and submissions with Regulatory colleagues.
• Participate in cross-functional teams and act as primary regulatory CMC contact for assigned products.
• Support regulatory assessments on product compliance topics including change controls, deviations and GMP investigations.

Connaissances

Regulatory knowledge

Interpersonal skills

Problem solving

Cross-functional collaboration

Planning & prioritization

Formation

Bachelor's degree in life science

Description du poste

Job Description

The Chemistry Manufacturing Controls Manager will be responsible for the detailed planning, preparation and operational execution of a multi-product program in the international region.

This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams.

Key Duties and Responsibilities

• Execute Lifecycle Management (LCM) strategy and submissions of marketed products with a focus in the international regions.
• 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
• Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
• Participates effectively in cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
• Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

Required Knowledge/Skills

• Strong interpersonal skills to exchange complex information with others and to guide others
• Proficiency in regulatory (FDA, EMA, ICH, international agencies) guidelines
• Strong problem-solving skills and the ability to present the overall assessment for management alignment
• Ability to collaborate and communicate in an open, clear, complete and timely manner
• Strong sense of planning and prioritization, with demonstrated results

Required Education Level & Experience

• Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
• Typically requires 5 years of experience in the pharmaceutical industry or related field
• Experience supporting Small Molecule programs required

Contract length: 12 months with the chance to extend.

Pay Range

$70/hr. - $80/hr.

Shift/Hours

Monday–Friday; Remote: EST hours