Manager, Regulatory CMC

Vertex Pharmaceuticals; Greater London; Hybrid; GBP 90,000 - 130,000; Full time

Job summary

A leading pharmaceutical company in London is seeking a Mid-Senior Regulatory Chemistry Manufacturing Controls Manager to influence global regulatory CMC strategies for investigational and marketed products. The ideal candidate should have strong interpersonal and regulatory skills, and a degree in a life-science field. This hybrid role involves interacting with cross-functional teams and regulatory agencies. The company offers a contract position, with employment managed through Talent Works.

Qualifications

• Bachelor's degree in a relevant life-science field.
• Experience in the pharmaceutical industry or related field.
• Strong knowledge of regulatory submission processes.
• Strategic thinker with strong problem-solving abilities
• Able to collaborate across cross-functional teams and senior management
• Excellent planning and prioritization capabilities
• Ability to resolve complex, ambiguous regulatory issues
• Sound knowledge of cGMP, FDA, EMA, ICH

Responsibilities

• Reviews CMC sections of regulatory submissions.
• Contributes to the development of global regulatory CMC strategies.
• Provides regulatory CMC guidance to cross-functional teams.
• Influences regulatory assessment on product compliance topics.
• Serves as primary regulatory CMC contact for products.
• Serve as primary CMC contact for assigned products/projects

Skills

Strong interpersonal skills

Proficiency in regulatory guidelines (SFDA, EMA, Health Canada, ICH)

Strategic thinking and problem-solving skills

Collaboration and communication skills

Planning and prioritization

Knowledge of cGMP, FDA, EMA, ICH

Problem solving

cGMP knowledge

Education

Bachelor's degree in Biology, Chemistry, Pharmacy

Experience in the pharmaceutical industry

Job description

Type of Role

Contract position, Inside IR35

Location

Hybrid, 3 days on site in Paddington, London.

Department

Regulatory – Chemistry Manufacturing Controls

General Summary

The Manager, Regulatory Chemistry Manufacturing Controls will influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products.

This role contributes to the preparation and submission of regulatory CMC documentation and with interactions with Health Authorities for CMC topics.

This role also provides regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs.

Key Duties and Responsibilities

• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.
• Contributes to the development of global regulatory CMC strategies for investigational and/or commercial products.
• Works with regulatory colleagues in development of global regulatory CMC strategies and submissions.
• Provides regulatory CMC guidance to cross-functional teams and key stakeholders.
• Influences regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
• Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects.

Knowledge and Skills

• Strong interpersonal skills to exchange complex information with others and to guide others.
• Proficiency in regulatory (SFDA, EMA, Health Canada and ICH) guidelines.
• Experience in the preparation, including writing, of CMC submissions.
• Strategic thinking and 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.
• Capable of strategic thinking with ability to resolve complex and ambiguous situations.
• Sound knowledge of cGMP, FDA, EMA, ICH.

Education and Experience

• Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
• Experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience.

Vertex is partnering with Talent Works to manage their international temporary job openings. If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.

Seniority Level

Mid-Senior level

Employment Type

Contract

Job Function

Other

Industries

Pharmaceutical Manufacturing