Current jobs related to Director Global Regulatory Affairs - UK, UK - EPM Scientific

  • Specialist – Regulatory Affairs PPP

    2 days ago

    UK, UK, United Kingdom VRS Regulatory Full time

    An opportunity to join the Regulatory Affairs team at an R&D focussed global PPP company. You will:Manage a portfolio of plant protection products in specific geographical territoriesDevelop regulatory strategy Become the subject matter expert on the regulations/guidelines in your territory. As a regulatory Specialist, you will develop regulatory strategy...

  • Global Head of Regulatory Affairs

    2 months ago

    UK, UK, United Kingdom Northreach Full time

    Northreach have partnered with an exciting pharma company based in the UK that are recruiting for a Global Head of Regulatory Affairs to join their team. . The role will lead the regulatory team, interfacing with regulatory agencies like the MHRA, EMA, FDA, preparing and submitting regulatory documents, and managing risk. The role requires a deep...

  • Regulatory Affairs Specialist – Chemistry/Analytical Methods

    2 days ago

    UK, UK, United Kingdom VRS Regulatory Full time

    Exciting opportunity to join the regulatory affairs team at an established and highly reputable chemical regulatory science consultancy. This is expansion to cover an increasing workload. The role is delivery focussed with no commercial or business development aspects. We are looking for a regulatory person for a purely regulatory delivery role. This role...

  • Regulatory Support Officer

    2 months ago

    UK, UK, United Kingdom VRS Regulatory Full time

    A rare opportunity for an aspiring regulatory affairs officer to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive training. An excellent opportunity to start and establish your career in...

  • Global Head of Regulatory Affairs

    2 months ago

    UK, UK, United Kingdom Essential Pharma Full time

    Essential Pharma are looking for a Global Head of Regulatory Affairs. You will be responsible for leading a small team, developing and implementing regulatory strategies, interfacing with our partners and regulatory agencies. We are looking for deep GxP knowledge, an excellent leader and relationship builder. Apply Today!What You Will DoDevelop and implement...

  • Regulatory Affairs Manager

    1 month ago

    UK, UK, United Kingdom Park Street People Full time

    An innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...

  • Head of Regulatory Affairs

    4 weeks ago

    UK, UK, United Kingdom SP GLOBAL CONSULTING LTD Full time

    Head of Chemical RegulationsLocation - Hybrid/ Remote Options AvailableSalary - Negotiable & related to level of experienceOur client is an international Service Company, operating in over 80 countries. They Provide Heath & Wellbeing Products and Services that protect people’s lives and the reputation of their customers brands.We are seeking a Head of...

  • Regulatory Affairs Associate

    2 months ago

    UK, UK, United Kingdom Cure Talent Full time

    Cure Talent is thrilled to partner with a leading Medical Devices Manufacturer, who due to continued growth, has an exciting opportunity for an experienced Regulatory Affairs Associate to join their team.As the new Regulatory Affairs Associate, you will be responsible for supporting global product registrations, maintaining design dossiers, and ensuring...

  • Regulatory Affairs Manager

    2 months ago

    UK, UK, United Kingdom Actalent Full time

    Regulatory Affairs Manager (UK & Ireland)As the Regulatory Affairs Manager for the UK and Ireland, you will report directly to the UK Country Manager. You will provide expert regulatory guidance to our UK organization and manage all regulatory activities across the UK and Ireland. Additionally, you will serve as the Local Person for Pharmacovigilance (LPPV)...

  • Senior Manager Regulatory Affairs

    2 months ago

    UK, UK, United Kingdom Blackfield Associates Full time

    Blackfield are pleased to be partnered with an international business, with a requirement for a Senior Manager, European Regulatory Affairs, to ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products.This role leads the European Regulatory Affairs team, partners with...

  • Product Stewardship Specialist

    3 weeks ago

    UK, UK, United Kingdom VRS Regulatory Full time

    Global household name speciality chemical companyResponsibility for National and Regional regulatory compliance Diverse business units – complex aqueous mixtures and substancesBecome a regulatory subject matter expert This will be a highly diverse role; typical duties include answering complex customer regulatory enquiries, researching/impact assessing...

  • Senior Manager, Quality Assurance and Regulatory Affairs

    1 month ago

    UK, UK, United Kingdom Emerald Lane Recruitment Part time

    Senior Quality Assurance and Regulatory Affairs ManagerPart-Time/Consultant Remote (Preference UK/EU Based)Our client is a licensed cannabis supplier of CBD/THC products to global pharmaceutical businesses, with business operations across multiple continents.They are seeking an experienced and dynamic Senior Quality Assurance and Regulatory Affairs Manager...

  • Regulatory Affairs Consultant

    2 weeks ago

    UK, UK, United Kingdom eTeam Full time

    Role: EMEA Regulatory Affairs ConsultantDuration: 5 MonthsLocation: High Wycombe, UK - Hybrid working (2 /3 days in High Wycombe office)KEY RESPONSIBILITIESManagement of post-approval activities for specified OTC products• Supports the EMEA Regulatory Affairs team for post-approval activities for MRP/DCP products across EEA and coordinate worksharing (WS)...

  • Regulatory Affairs Manager

    2 weeks ago

    UK, UK, United Kingdom LanceSoft, Inc. Full time

    Title: Regulatory Affairs ManagerDuration: Till March 2024Location: Hybrid. 1 - 2 days in the office per week at High Wycombe HP12 4PTNotes: Inside IR35 - till March 2024 initially - OTC experience is essential.Job Description:EMEA REGULATORY AFFAIRS –REGULATORY CONSULTANTKEY RESPONSIBILITIESManagement of post-approval activities for specified OTC...

  • Regulatory Affairs Manager

    2 weeks ago

    UK, UK, United Kingdom CK Group Full time

    CK Group are recruiting for a Regulatory Affairs Manager, to join a company in the Pharmaceutical industry, at their site based in High Wycombe, on a contract basis to the end of March 2025.Salary: Hourly £61.00 per hour PAYE or £82.00 per hour Umbrella.Regulatory Affairs Manager Role:Management of post-approval activities for specified OTC...

  • Senior Regulatory Affairs Associate

    1 month ago

    London, UK, UK, United Kingdom Park Street People Full time

    Our client, a global pharmaceutical company, is currently looking for a Senior Regulatory Affairs Associate to join their team in Cambridge or West London (Uxbridge). This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their...

  • Regulatory Affairs Specialist

    3 weeks ago

    UK, UK, United Kingdom Athsai Full time

    Precision Medicine & Digital Health - Regulatory Affairs Specialist studioChester, Uxbridge or MoretonMust have list:1. In vitro diagnostics regulations in precision medicine under US and EU regulations2. Worked on drug trials that use a biomarker to select patients into the trial, include but not limited to, understand clinical trial assay (CTA)...

  • Ecotoxicology Risk Assessment Specialist

    1 month ago

    UK, UK, United Kingdom VRS Regulatory Full time

    An opportunity to join the Chemical Regulatory science team at an R&D focussed global PPP company. We are looking for an:Ecotoxicology regulatory specialist 2-5 years industry experienceIdeally with aquatic knowledge and some experience of risk assessment. The role involves developing data, risk assessments and producing the ecotoxicology section of...

  • Senior Regulatory Affairs Associate

    1 month ago

    UK, UK, United Kingdom Cure Talent Full time

    Cure Talent are delighted to be working with a well-established Medical Device company that supply and distribute innovative Medical Devices. Due to their continued growth and success, we have an exciting opportunity for a Senior Regulatory Affairs Associate to join them in West Yorkshire.As the new Senior Regulatory Affairs Associate, you will be working...

  • Regulatory Affairs Consultant

    4 weeks ago

    UK, UK, United Kingdom Fusion Pharma Limited Full time

    *No recruiters please*Regulatory Affairs Consultant, Fusion Pharma THE COMPANYWe are Regulatory Affairs experts who specialise in the UK and EU pharmaceutical industry, we offer a bespoke consultancy service to our clients. Our first priority is to have a positive workplace culture where employees feel respected and valued. To achieve this, we only hire...

Director Global Regulatory Affairs

3 months ago

UK, UK, United Kingdom EPM Scientific Full time

Director Global Regulatory Affairs


ABOUT THE ROLE

The Director, Global Regulatory Affairs will be responsible for developing, implementing and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.


Global Regulatory Affairs is expected to:

• Provide high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approvals in international markets, regulatory strategic development plans and risk assessments and lead Health Authority interactions.

• Oversee, contribute to and/or prepare regulatory submissions

• Perform and prepare due diligence assessments that may include risk mitigation strategies

• Prepare regulatory teams for and lead meetings, including face-to-face, with Health Authorities

• Continually build upon and maintain knowledge base of global regulatory landscape, regulations and guidance.

• Manage the development of the ongoing global regulatory strategy

• Marketing access activities including pricing/contracts/product listings


ESSENTIAL REQUIREMENTS FOR ROLE

• Postgraduate degree (MS/PhD/PharmD) in Pharmacy, Biological Sciences, or other related discipline.

• 15+ years global regulatory affairs experience with increasing leadership in the pharmaceutical/biotechnology industry

• Solid knowledge of FDA, EMA and other global regulations and ICH guidelines

• Expert in product development and experience in early to late stage as well as post approval phases

• Demonstrated experience in leading face-to-face meetings with FDA, EMA and/or other Health Authorities

• Preparation of New Drug Applications and Marketing Authorisation Applications in eCTD format • Obtain Orphan Drug Designations in Europe and US

• High level of personal integrity and ethical behaviour

• Strong leadership and staff development skill