Manager, Regulatory CMC

15 hours ago

City Of London, United Kingdom Talent Works Full time

Role: Manager, Regulatory CMC Company Name: Vertex Pharmaceuticals Type of Role: Contract position, Inside IR35 Contract length: 14 months Location: Hybrid, 3 days on site in Paddington, London. Department: Regulatory – Chemistry Manufacturing Controls Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases. 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. #J-18808-Ljbffr

  • Expert, CMC Regulatory Strategy

    7 days ago

    City Of London, United Kingdom Ipsen Full time

    OverviewJoin to apply for the Expert, CMC Regulatory Strategy role at Ipsen.As an Expert, CMC Regulatory Strategy, you will be responsible for preparing CMC regulatory strategies for assigned projects under the strategic direction of the Manager or Director. You will contribute to the development of effective CMC regulatory dossiers aligned with defined...

  • CMC Mature Products Regulatory Manager

    2 weeks ago

    City Of London, United Kingdom GSK Full time

    CMC Mature Products Regulatory Manager – GSK Site Name: USA - Pennsylvania - Upper Providence, Baar Onyx, Belgium-Wavre, GSK HQ, Poznan Grunwaldzka, USA - Massachusetts - Waltham, USA - North Carolina - Durham, Ware Posted Date: Oct 16 2025 Job Purpose: Responsible for the CMC regulatory activities in the commercial lifecycle management of GSK products....

  • Expert, CMC Regulatory Strategy

    7 days ago

    City Of London, United Kingdom Ipsen Group Full time

    Cookie NoticeExpert, CMC Regulatory Strategy page is loaded## Expert, CMC Regulatory Strategylocations: London (UK): Paristime type: Full timeposted on: Posted Todayjob requisition id: R-20043**Title:**Expert, CMC Regulatory Strategy**Company:**Ipsen Biopharm Ltd**About Ipsen:**Ipsen is a mid-sized global biopharmaceutical company with a focus on...

  • Manager, Regulatory CMC

    21 hours ago

    London, Greater London, United Kingdom Talent Works Full time

    Role:Manager, Regulatory CMCCompany Name: Vertex PharmaceuticalsType of Role: Contract position, Inside IR35Contract length: 14 monthsLocation: Hybrid, 3 days on site in Paddington, London.Department: Regulatory – Chemistry Manufacturing ControlsLooking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology...

  • (Associate) Director, Regulatory Affairs CMC

    1 week ago

    City Of London, United Kingdom Autolus Limited Full time

    (Associate) Director, Regulatory Affairs CMC page is loaded## (Associate) Director, Regulatory Affairs CMClocations: UK - London, White City: UK - Stevenagetime type: Full timeposted on: Posted Todaytime left to apply: End Date: January 5, 2026 (30+ days left to apply)job requisition id: JR100066**Work with us** Our team are passionate in the...

  • Senior Director, Regulatory Affairs

    1 week ago

    City Of London, United Kingdom Perrigo Company plc Full time

    Senior Director, Regulatory Affairs – CMC, Regulatory Operations & Lifecycle Management Join Perrigo Company plc as Senior Director, Regulatory Affairs – CMC, Regulatory Operations & Lifecycle Management. At Perrigo, we are driven by our mission to make lives better through trusted health and wellness solutions, accessible to all. We are proud to be a...

  • Regulatory CMC Manager — Hybrid

    17 hours ago

    City Of London, United Kingdom Talent Works Full time

    A leading biotechnology company in London seeks a Manager, Regulatory CMC to drive multi-product global regulatory strategies. This role involves reviewing regulatory submissions, guiding cross-functional teams, and ensuring compliance with global regulatory requirements. Candidates should have a Bachelor's in a relevant field and strong interpersonal...

  • Expert, CMC Regulatory Strategy

    2 weeks ago

    London, Greater London, United Kingdom Ipsen Full time

    WHAT - Summary & Purpose Of The PositionAs an Expert, CMC Regulatory Strategy, you will be responsible for preparing CMC regulatory strategies for assigned projects under the strategic direction of the Manager or Director. You will contribute to the development of effective CMC regulatory dossiers aligned with defined roadmaps to optimize time-to-market for...

  • Expert, CMC Regulatory Strategy

    1 week ago

    London W, United Kingdom IPSEN Full time

    WHAT - Summary & Purpose of the PositionAs an Expert, CMC Regulatory Strategy, you will be responsible for preparing CMC regulatory strategies for assigned projects under the strategic direction of the Manager or Director. You will contribute to the development of effective CMC regulatory dossiers aligned with defined roadmaps to optimize time-to-market for...

  • Expert, CMC Regulatory Strategy

    2 weeks ago

    London, Greater London, United Kingdom Ipsen Full time

    Title:Expert, CMC Regulatory StrategyCompany:Ipsen Biopharm LtdAbout Ipsen:Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle...