Senior Regulatory Affairs

4 weeks ago


London, Greater London, United Kingdom Cpl Full time

Job Title: Senior Regulatory Affairs & PV Manager

Employment Type: Permanent position

Location: East London, 3 days on site. (Hybrid)

Remuneration: Competitive salary and package

Senior Regulatory Affairs & PV Manager opportunity working for a growing pharmaceutical company specialising in medicinal, non-medicinal, medical devices, and OTC products. The business is increasingly growing and is looking for a personable and detail-oriented professional to join the team and lead the RA and PV Team (4 individuals).

This role will have a main focus on UK and European submissions through MRP, DCP, and National procedures managing over 150 licenses. You will be responsible for managing regulatory submissions, MA Transfers, Initial MAA's, new registrations, and variations applications.

Responsibilities

· Manage required regulatory processes for UK and European products including submitting submissions through National MRP and DCP.

· Define, develop, and leads regional strategies to maximize regulatory and pharmacovigilance success.

· Sound knowledge of requirements of MA Transfer in EU territories, which includes requirements of notarization and translations.

· Oversight a team of 4 to ensure day-to-day activities are carried out in Regulatory and Pharmacovigilance.

· Drive all pre-submission meetings including inputting into scientific advice meetings.

· Be responsible for all initial/new MAA applications into main EU countries.

· Following MA approvals ensure product maintenance including submission of national variations or notifications.

· Ensure EU and UK product labelling approval and compliance with the MA approval activities.

· Successfully interact with the MHRA and any EU UK Regulatory Authority. Ensuring that regulatory processes are completed and products are launched in line with regulatory requirements.

· Generate and implement local procedures and processes to ensure regulatory compliance is met for EU and UK portfolios.

Requirements

· Bachelor's degree or higher in Life Sciences or technical field.

· 5 to 10 years of relevant regulatory experience especially within the UK and European markets. Submitting through MRP, DCP and national procedures.

· A strong communicator who is able to navigate through difficult conversations with senior stakeholders.

· Good team working skills, able to influence to achieve objectives.

This position allows for the right candidate to work for a growing pharmaceutical company and take charge of UK and European submissions. The role will play a pivotal part in the Regulatory Affairs and PV team and ensure all compliance. The role includes some excellent benefits including a generous bonus scheme.

To apply for this role you must have the full right to work in Europe as this employer does not provide sponsorship. For more information please contact



  • Uxbridge, London (Greater), Uxbridge, London (Greater), London, United Kingdom i-Pharm Consulting Full time

    Regulatory Affairs Manager (Inside IR35)Duration: 12 months (Extention possible)Location: Uxbridge, 3 days on-site per weekHourly Rate: £40-£55 per hour dependant on experience.Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a key member of the Global...


  • London, Greater London, United Kingdom Abbott Laboratories Full time

    ABOUT LINGOMeet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of...


  • London, Greater London, United Kingdom JR United Kingdom Full time

    Senior Global Medical Director – Rare Disease This Senior Medical Director role is the Global Medical Affairs Asset Lead for a recently acquired compound. Alongside the cross functional Asset Leads and as part of the Asset team, you will be accountable for developing and delivering the Global Medical Affairs strategy in order to achieve the agreed...


  • London, Greater London, United Kingdom Hanson Search Full time

    Seeking a dynamic and experienced Senior Account Manager to join the New York office of a Global Corporate Affairs Agency.


  • London, Greater London, United Kingdom CHM Full time

    Our client, a children's charity are seeking an experienced policy and public affairs professional to manage and provide leadership to their central Policy and Public Affairs team.Senior Policy, Public Affairs and Development ManagerAdvertising Reference: 2385Location: London Office – Mentmore TerraceStatus: Permanent term. 35 hours per week.Salary:...


  • London, Greater London, United Kingdom Hanson Search Full time

    Hanson Search have an opening for a Public Affairs researcher to join the team and support our senior members to headhunt and attract Public Affairs talent.


  • London, Greater London, United Kingdom King's College London Full time

    Location: St Thomas' CampusContact details: Dr Clare Heaysman. About usWe are seeking experts in medical device design regulatory processes to join our team and work with project groups to translate novel technologies to the clinic.We welcome applications from individuals with experience in:Regulatory Affairs supporting MedTech start-up organisationsQuality...


  • London, Greater London, United Kingdom Michael Page Legal Full time

    Varied complex regulatory work for a regulatory energy specialist lawyer. Power, Infrastructure & Energy Projects - Decommissioning, Regulatory & Risk.Client Details Our client is the owner and operator of multiple power generation assets in the UK, Ireland and Globally. DescriptionThe organisation's team includes commercial, technical, financial and legal...


  • London, Greater London, United Kingdom Noble Legal Limited Full time

    Are you a senior level Financial Services Regulatory lawyer who would be interested in moving into a Professional Support/Knowledge lawyer role at a major international law firm?As the sole PSL for the firm's highly regarded FS Regulatory group, you will work closely with partners and senior fee earners, and will actively support them in the development of...

  • FS Regulatory Lawyer

    1 month ago


    London, Greater London, United Kingdom MAP Legal Recruitment Full time

    FS Regulatory Lawyer - Mid/Senior AssociateWe are instructed by an international law firm that is seeking to recruit a mid/senior level Associate to join their financial services regulatory team in London.This highly regarded team advise their clients on governance, conduct and market issues and they are well known for their regulatory, advisory,...


  • London, Greater London, United Kingdom Grist Legal Recruitment Full time

    Solicitor Regulatory BarristerA leading Regulatory department require experienced Senior Regulatory Barrister to undertake Tribunal representation. The role offers hybrid and flexible working out of the firm's London office.The successful Senior Solicitor Regulatory Barrister will primarily present cases at final substantive hearing and represent regulators...


  • London, Greater London, United Kingdom Grant Thornton UK Full time

    More than you expected Grant Thornton UK LLP is part of a global network of independent audit, tax and advisory firms, made up of some 58,000 people in over 135 countries. We're a team of independent thinkers who put quality, inclusion and integrity first. All around the world we bring a different experience to our clients. A better experience. One that...

  • senior legal

    1 month ago


    London, Greater London, United Kingdom Kinsella Legal Full time

    SENIOR LEGAL & BUSINESS AFFAIRS EXECUTIVESCRIPTED TV PRODUCTIONLONDON / HYBRID4/5 DAYSOur client is one of the UK's leading television production companies. Over the last twenty years it has enjoyed an exceptional output of outstanding original scripted television comedy and drama with a track record of nurturing talent.We have an exciting opportunity for a...


  • London, Greater London, United Kingdom Noble Legal Limited Full time

    An international law firm is looking to hire a senior regulatory lawyer to join their team in the City. The role offers a large degree of client contact, the chance to build and develop their own business and exposure to market-leading work.The new joiner will be expected to be involved with all elements of non-contentious regulatory work with a particular...

  • Senior Medical Writer

    1 month ago


    London, Greater London, United Kingdom CM Consulting Full time

    Role Summary: Our client is seeking a Senior Medical Writing to join their growing, London-based team. The ideal candidate will be an experienced writer with previous agency experience in medical affairs, commercial and marketing activities, public affairs, or all of the above.The Client: The client is a small, creative, collaborative agency who believe that...


  • London, Greater London, United Kingdom Hanson Search Full time

    A leading strategic communications consultancy is seeking a public affairs/corporate communications Account Director or Senior Account Director in London.


  • London, Greater London, United Kingdom Michael Page Legal Full time

    An exciting opportunity to work as a Regulatory and Investigations Professional Support Lawyer supporting our client's London-based legal regulatory and investigations team and their wider disputes team.Client DetailsOur client is one of the world's largest and most well-respected law firms.DescriptionAs a Regulatory and Investigations Professional Support...


  • London, Greater London, United Kingdom Eximius Law Full time

    Exciting new regulatory role to work in a growing fintech business in the City of London. This role directly reports to Head of Legal and working closely with other senior stakeholders.In this role you will advise on complex regulatory matters and work across multiple regions and jurisdictions, as well as pro-actively identifying and managing legal risks....


  • London, Greater London, United Kingdom Kinsella Legal Full time

    SENIOR LEGAL & BUSINESS AFFAIRS EXECUTIVESCRIPTED TV PRODUCTIONLONDON / HYBRID6 MONTH + CONTRACTASAP STARTOur client is a global leading television production company. It makes outstanding and original scripted television comedy and drama, which makes one of the most exciting and successful companies to work with.A temporary (or temp to perm) opportunity has...

  • fs regulatory partner

    1 month ago


    London, Greater London, United Kingdom Noble Legal Limited Full time

    This profitable City / International firm are experienced in a wide range of both cross-border and domestic financial services regulation. Their impressive client roster ranges from large multinationals to specialist boutiques. They work with banks, investment and asset managers, payment services providers, brokers and other financial markets participants. ...