Jobs
>
London

    Regulatory Affairs Manager - England, United Kingdom - Blackfield Associates

    Default job background
    Description

    Job Description

    Our client, an independent pharmaceutical company who manufacture and specialising in generics, have an opportunity for an experienced EU/ UK Regulatory team leader to join their team in Hampshire.

    As Regulatory Affairs manager, you will:

    • Leading a small team, handling the regulatory activity across a large portfolio of medicine and medical device/ combination products
    • Working with EU, UK, and RoW regulatory bodies; as the subject matter expert for Medicines; Medical Devices and related ISO activities (including ISO13485 and ISO14971); Controlled Drugs; Nutritional Products; In Vitro Diagnostic Devices; Biocidal Products
    • Review and support for submission of new product dossiers and technical files – both own development, in-licensed and out-licensed and all aspects of regulatory lifecycle maintenance for existing products
    • Author technical documentation, including EU eCTD dossier sections, technical file documents and product artwork, for alignment with applicable regulations and guidance and assessing suitability for submission where appropriate.
    • Regulatory Strategy and Scientific Writing
    • Finial signatory on artwork and labelling material

    To be considered for the role of Regulatory Affairs Manager, you will:

    • Minimum of 5 years of Regulatory Affairs experience in a relevant pharma environment
    • Educated to degree level in a relevant life science discipline
    • Previous line/people management experience
    • Well versed in Project Management/ larger portfolio
    • Must have proven experience with EU and UK regulations for medicinal products/ devices

    Due to the nature of the team, this person will be required at the Hampshire office at least 3 times a week. Hybrid working.

    #J-18808-Ljbffr


  • Hays Specialist Recruitment Limited London, United Kingdom

    Exciting Senior Public Affairs Manager role based in London · **Your new company** · I am currently recruiting for a Senior Public Affairs Manager to join my client's talented workforce. Based in London, you will have the opportunity to collaborate with inspiring and motivated in ...


  • membershipbespoke London, United Kingdom

    **Policy and Public Affairs Manager** · **Professional Membership Body** · **Hybrid working (central London and home)** · **Salary: £45,588 plus a generous benefits package** · **Full-time, Permanent** · My client, a leading professional membership body based in Central London wi ...


  • Advanced Resource Managers Limited London, United Kingdom

    **Senior Public Affairs Officer - London - 3-month contract - £31.30 Umbrella rate** · ARM are working with a well-known transportation client who are currently involved with transportation in the UK. We are currently recruiting for an experienced Senior public Affairs Officer to ...


  • Legal & General London, United Kingdom Permanent

    We're recruiting for a Public Affairs Managerto join us. You will help deliver Legal & General's engagement programme with government, parliamentarians, and policymakers; provide political analysis to support the Group in making strategic decisions; and help ensure Legal & Genera ...


  • Planet Pharma United Kingdom

    Role: Regulatory Affairs Associate Manager - Cosmetics · Location: Home-based anywhere in the UK · Job Type: 6+ Month contract · Salary / Rate: Very competitive hourly rate · Planet Pharma are partnered with a niche mid-sized CRO assisting them with the search for an Associate M ...


  • AstraZeneca London, United Kingdom Full time

    Medical Affairs Manager – GU/GYN · London Pancras Square · Competitive Salary & Benefits · As the Medical Affairs Manager, you will play a key role in providing clinical insights, maintaining a strong customer focus, and ensuring clinical governance aligns with the Medical and ...


  • Novelis Latchford London, United Kingdom Full time

    Novelis is driven by its purpose to shape a sustainable world together. · Who we are: · As a global leader in innovative products and services and the world's largest recycler of aluminum, we partner with customers in the automotive, beverage can, aerospace and specialties indust ...


  • Morgan McKinley London, United Kingdom

    Title: Business Affairs Manager (Native 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. ...


  • Pharma Partners Recruitment Ltd London, United Kingdom

    Job title: Regulatory Affairs Manager · A Pharmaceutical company in London are seeking a Regulatory Affairs Manager to join their team. This role will be responsible for providing regulatory strategy for new marketing authorizations as well as life cycle management for their cur ...


  • Phoenix Group Holdings London, United Kingdom Permanent

    Job Type : Permanent · Location: This role will be based in our London office with time spent working in the office and at home. · Flexible working: All of our roles are open to part-time, job-share and other types of flexibility. We will discuss what is important to you and ba ...


  • Legal & General London, United Kingdom

    Helping over ten million people around the world manage their savings, retirement plans and life insurance requires a lot of people behind the scenes. It's up to us in L&G Group functions – which includes our tech and digital teams, Group Finance, HR, Risk and Corporate Affairs – ...


  • Arthur Edward London, United Kingdom Full time

    Regulatory Affairs Manager – London – £50-55, · Are you a regulatory professional with International experience, ready to take on the world? · Can you help a disruptor brand to create compliant products that captivate consumers? · Step into a company that is famed for disruptiv ...


  • Cpl Life Sciences United Kingdom

    Job Title: Regulatory Affairs Manager · Job Type: 12-Month Contract (inside IR35) · Location: Uxbridge or Cambridge – 1 day on-site per month · Rate: £45 to £55 per hour (PAYE) · This role will support one or more products from a regional regulatory perspective. As a member of th ...


  • Cpl Life Sciences London, United Kingdom

    Job Title: Regulatory Affairs Manager (CTA/ CTR) · Job Type: Permanent, full-time · Locations: UK, Italy, Spain, Sweden or the Republic of Ireland – Remote based · Remuneration: £50,000 to £65,000 + benefits · Regulatory Affairs Manager opportunity working for a cutting edge Onc ...


  • Inventum Group London, United Kingdom

    We have partnered with a leader in Healthcare. This is a new opportunity within the UK Corporate Affairs team for someone to join to work on Campaigns In this role, you will be responsible for the execution of a new campaign, a cross Corporate Affairs initiativethat seeks to posi ...


  • Aquent London, United Kingdom

    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 communications. · PLEAS ...


  • Cpl Life Sciences United Kingdom

    Job Title: Regulatory Affairs Manager · Job Type: 12-Month Contract (inside IR35) · Location: Uxbridge or Cambridge – 1 day on-site per month · Rate: £45 to £55 per hour (PAYE) · This role will support one or more products from a regional regulatory perspective. As a member ...


  • CK Group London, United Kingdom

    CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company who are based in Cambridge on a contract basis for 12 months. · Company:nOur client is committed to unlocking the potential of biology for patients suffering from serious illnesses by dis ...


  • Cpl Healthcare London, United Kingdom

    Job Title: Regulatory Affairs Manager (CTA/ CTR) · Job Type: Permanent, full-time · Locations: UK, Italy, Spain, Sweden or the Republic of Ireland – Remote based · Remuneration: £50,000 to £65,000 + benefits · Regulatory Affairs Manager opportunity working for a cutting ed ...


  • MSI Pharma England, United Kingdom

    We are seeking a dynamic and experienced professional to join our client's team as a Manager of Regulatory Affairs (RA) with a passion for innovation in the Self Care industry. You will lead a team responsible for the development of regulatory strategies and provide technical gui ...