Jobs
>
London

    Regulatory Affairs Manager - United Kingdom - PE Global

    PE Global
    Default job background
    Description


    PE Global is currently recruiting for a Regulatory Affairs CMC Manager for a contract role with a leading multinational Biotech client based in London – Fully remote within the UK.Regulatory CMC support for post-approval submissions for commercial products, predominantly biotechnology products and new international MAA filings predominantly in EMEA region.

    Reporting to Executive Director.

    Job Responsibilitiesregulatory CMC at relevant site meetings and provide timely and accurate feedback to support site initiatives.compilation and project management of all necessary documentation for commercial regulatory CMC submissions and response to questions.

    Ensure submissions are high quality; the content and format of regulatory submissions comply with application regulations and guidelines governing the development, licensure and marketing of chemical drugs, biologics or gene U.S.

    and UK/Shanbally teams to prepare change controls and GMP documentation to support global submissions for product registrations and/or cross-functional project teams as a regulatory CMC representative for project specific discussions.

    Ensure consistent communication within the department and with other functional areas.identifying issues and suggesting appropriate strategies to mitigate the preparation for interactions with global regulatory authoritiesRequirementsof generating global regulatory strategy documents.ability to lead SME team of authors to generate variation/supplement content enabling Right First-Time approvals.knowledge of regulatory legislation and CMC guidance in EU, US and ICH international MAA and post-approval filings essential.knowledge of regulatory submissions for biotech Agency interaction preferred.

    Interested candidates should submit an updated CV. Please click the link below to apply, call Veronica on or alternatively send an up to date CV to
    Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK


  • CK GROUP London, United Kingdom

    CK Group are recruiting for a Medical Affairs Manager to join a company in the Pharmaceutical industry working initially on a contract basis for 6 months. · **Daily Rate**: · £500 Per Day / £275 Half Day Ltd - this role is outside IR35 · **Essential Requirements**: · - Registered ...


  • STR Group Limited London, United Kingdom

    **Regulatory Affairs Manager - UK Steel** · **Permanent** · **Hybrid working - London based (SW1H). Travel Required** · **Full time** · **Competitive salaries and excellent benefits including matched pension contributions up to 8%** · **UK Steel | Make UK** · **The Manufacturers' ...


  • National Housing Federation London, United Kingdom

    **External Affairs Manager** · **Salary**:£46,100 (London) / £42,000 (National) per annum · **Hours**:35 hrs per week · **Contract**:Permanent · **Location**:London, Bristol or homeworker. · **Benefits** · - 27 days annual leave + statutory holidays + 3 closures days over the Chr ...


  • Blue Pelican London, United Kingdom

    **Role: Public Affairs Manager** · **Location**: Hybrid - in office twice a week. Heavily subsidised travel. · **Salary**: Up to £48,000 plus benefits · This is a 12 month maternity cover contract engagement. The current role holder is due to finish up at the end of January. · Ov ...


  • CK GROUP Switzerland, United Kingdom

    CK Group is recruiting for a Regulatory Affairs Manager to join a global pharmaceutical company who are patient-focused, values-based, R&D-driven company committed to bringing better health and a brighter future to people worldwide. The position will bebased in Zurich, with some ...


  • Page Group London, United Kingdom

    Regulatory Affairs Manager (ESG & Market Infrastructure) · **Client Details** · Global financial services membership body. · **Description** · I am currently recruiting for a Regulatory Affairs Manager (ESG & Markets Infrastructure) with a global financial services membership bod ...


  • EMR London, United Kingdom

    **Senior External Affairs Manager** · **Senior External Affairs Manager needed for a nationwide facilities and property business** · **Salary: Up to £70,000 DOE** · **Location: Central London - Very Flexible Working Policy** · **Contract: 12 Month FTC** · A role responsible for t ...


  • CK GROUP London, United Kingdom

    CK Group are recruiting for a Senior Regulatory Affairs Manager to join a highly successful pharmaceutical company with a strong portfolio of marketed and developmental products. This is an exciting time for the company as they move to later phase developmentand marketing authori ...


  • The Institution of Engineering & Technology Stevenage, United Kingdom

    **Public Affairs Manager** · **Circa £45,000 per annum, dependent on experience** · **Permanent/Full-time** · **Stevenage, Hertfordshire (with Hybrid working)** · What if you worked for an organisation where you influenced policy development? · What if you were increasing the pro ...


  • Hanson Search London, United Kingdom

    Job Description · PUBLIC AFFAIRS MANAGER - PART TIME (3 DAYS PER WEEK) · An exciting opportunity to join an independent, non-profit, government-backed energy organisation, who are looking for a Public Affairs Manager, in either London or Edinburgh. · Within the role, you will lea ...


  • WALKER COLE INTERNATIONAL LTD South East England, United Kingdom

    Walker Cole International is currently supporting one of their Global Pharmaceutical clients in the South-East of England to hire a Regulatory Affairs Manager on a contract basis, outside IR35 or via umbrella company if needed. · The key responsibilities are: · - Provide a Regula ...


  • Aquent London, United Kingdom

    Job Description · THE OPPORTUNITY · We are looking for a Business Affairs Manager to work within the French market for our clients Global Marketing Communications group. They oversee advertising and marketing to ensure the flawless development and execution of world-class communi ...


  • Morgan McKinley London, United Kingdom

    Job Description Title: Business Affairs Manager (Fluent French Speaker) · Duration: 12 months contract · Location: London (hybrid) · Job Summary: · In this role, the successful candidate will be representing Business Affairs team with a high degree of ownership, integrity, and ...


  • Morgan McKinley London, United Kingdom

    Title: Business Affairs Manager (Fluent French Speaker) · Duration: 12 months contract · Location: London (hybrid) · Job Summary: · In this role, the successful candidate will be representing Business Affairs team with a high degree of ownership, integrity, and accountability. As ...


  • Control Now United Kingdom

    Job Title : Regulatory Affairs Manager (ASIC/MAS) · Team: Regulatory Affairs · Location: Remote working with offices in London & Sofia · Rate: Competitive, + commission, + share options · Date available: June 2024 · Job type: Full Time · Line Manager: Interim - Head of ...


  • Aquent London, United Kingdom

    Job Description · THE OPPORTUNITY · We are looking for a Business Affairs Manager to work within the French market for our clients Global Marketing Communications group. They oversee advertising and marketing to ensure the flawless development and execution of world-class communi ...


  • ICON Strategic Solutions England, United Kingdom

    Regulatory Affairs Manager- (EU CTR) Homebased in UK/Ireland Only · Due to recent success within one our Innovative Biotech Clients I am recruiting for a Regulatory Affairs manager at ICON - Working in a client-dedicated yet fully embedded role ICON's Regulatory Strategy group, y ...


  • Control Now Greater London, United Kingdom

    Job Description · Job Title: Regulatory Affairs Manager (ASIC/MAS) · Team: Regulatory Affairs · Location: Remote working with offices in London & Sofia · Rate: Competitive, + commission, + share options · Date available: June 2024 · Job type: Full Time · Line Manager: Interim - H ...


  • Revolut London, United Kingdom Full time

    About Revolut People deserve more from their money. More visibility, more control, more freedom. And since 2015, Revolut has been on a mission to deliver just that. With an arsenal of awesome products that span spending, saving, travel, transfers, investing, exchanging and more, ...


  • Aquent London, United Kingdom

    THE OPPORTUNITYWe are looking for a Business Affairs Manager to work within the French market for our clients Global Marketing Communications group. They oversee advertising and marketing to ensure the flawless development and execution of world-class communications.PLEASE NOTE T ...