Regulatory Affairs Manager

3 weeks ago


Maidenhead, Windsor and Maidenhead, United Kingdom Proclinical Staffing Full time
Main Responsibilities
  • Strategic Regulatory Leadership: Provide strategic regulatory guidance to support product launches in Central Eastern Europe and the Middle East.
  • Collaboration and Communication: Work closely with supply chain, quality assurance, and commercial/medical teams to ensure compliance with country-specific regulatory requirements and manage potential risks.
  • Regulatory Submissions and Due Diligence: Prepare and deliver regulatory submissions throughout the product lifecycle and conduct regulatory due diligence assessments with Business Development.
  • Regulatory Information Management: Contribute to the preparation and implementation of a Regulatory Information Management system (RIM) and maintain a dashboard of country-specific regulatory activities.

As a Regulatory Affairs Manager with Proclinical Staffing, you will be responsible for providing strategic regulatory leadership and support to product launches in Central Eastern Europe and the Middle East. This role involves collaboration with various teams to ensure compliance with country-specific regulatory requirements and managing potential risks. You will work closely with supply chain, quality assurance, and commercial/medical teams to identify regulatory requirements and risks. Your expertise will be crucial in preparing and delivering regulatory submissions throughout the product lifecycle and conducting regulatory due diligence assessments with Business Development. You will also contribute to the preparation and implementation of a Regulatory Information Management system (RIM) and maintain a dashboard of country-specific regulatory activities.

This role requires a strong understanding of European regulatory requirements for innovative products. You will be responsible for providing strategic regulatory guidance to support product launches and ensuring compliance with country-specific regulatory requirements. Your collaboration and communication skills will be essential in working closely with various teams to manage potential risks and ensure regulatory compliance.

As a Regulatory Affairs Manager with Proclinical Staffing, you will have the opportunity to work on a variety of projects and contribute to the growth and success of the company. You will be working with a team of professionals who are passionate about their work and committed to delivering high-quality results. This is an excellent opportunity for a Regulatory Affairs professional to take their career to the next level and make a real impact in the industry.



  • Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full time

    Job Title OverviewThe Regulatory Affairs Project Manager will support the Regulatory Affairs Manager's vision and leadership by providing patient-centric and compliant regulatory expertise.  Key ResponsibilitiesSupport the business of the company, including involvement in product launches, acquisitions, and divestitures as a Regulatory Affairs...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full time

    Fortrea, a leading global contract research organization, is seeking a skilled Regulatory Affairs Specialist to support the preparation and submission of key documentation to regulatory authorities for new clinical trials. The ideal candidate will have a strong understanding of regulatory guidelines and legislation related to drug and biologic products.Key...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time

    An exciting opportunity has become available with Select Pharma Limited, a growing pharmaceutical company, for an experienced and enthusiastic Regulatory Affairs professional wishing to expand their experience and knowledge in a growing Reg team. With a focus on post-approval activities, the successful candidate will gain exposure to many aspects of...


  • Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full time

    Job OverviewThe Regulatory Affairs Project Manager plays a crucial role in supporting the Regulatory Affairs Manager's vision and leadership by providing patient-centric and compliant regulatory expertise. They represent the department and affiliate within AbbVie, ensuring the best interests of patients, the Affiliate, and AbbVie are upheld during...


  • Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full time

    Job OverviewThe Regulatory Affairs Project Manager plays a pivotal role in supporting the Regulatory Affairs Manager's vision and leadership by providing patient-centric and compliant regulatory expertise. They represent the department and affiliate within AbbVie, ensuring the best interests of patients, the Affiliate, and AbbVie are upheld during...


  • Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full time

    Job OverviewThe Regulatory Affairs Project Manager at AbbVie supports the department's vision by providing patient-centric and compliant regulatory expertise. They represent the company within regulatory agencies, ensuring the best interests of patients, affiliates, and AbbVie are upheld during interactions.This role contributes to the department's success...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time

    Are you an enthusiastic Regulatory Affairs professional looking to expand your experience and knowledge in a growing pharmaceutical company? We have an exciting opportunity for a skilled Chemical Regulatory Specialist to join our team!About the Role:We are seeking an experienced professional to lead post-approval activities, ensuring compliance with...


  • Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full time

    Job Title: Medical Director of Oncology AffairsAbout the Role:This is a senior leadership position that requires a highly skilled and experienced professional to lead our Oncology Medical Affairs team in the UK.Main Responsibilities:Lead the development and execution of the Oncology Medical Affairs strategy in the UKBuild and manage a high-performing team of...


  • Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full time

    Director of Oncology Medical AffairsAt AbbVie, we are seeking a highly skilled Director of Oncology Medical Affairs to lead our UK Oncology Medical Affairs Department. This is a critical leadership role that requires a strong background in oncology, experience in managing complex teams, and a deep understanding of the pharmaceutical industry.Key...


  • Maidenhead, Windsor and Maidenhead, United Kingdom CSL Behring Full time

    Role OverviewWe are seeking an experienced Senior Pharmacovigilance Specialist to join our team at CSL Vifor, responsible for managing the local pharmacovigilance system within CSL Vifor UK and Ireland.You will work closely with colleagues to establish and maintain local PV systems in compliance with national regulations and GSPV policies, ensuring seamless...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Proclinical Staffing Full time

    Proclinical Staffing, a leading life sciences recruiter, is seeking an experienced medical professional to support their medical affairs team for a period of one year.Job SummaryThe ideal candidate will excel in delivering field-led projects, collaborating with cross-functional teams, and maintaining a high focus on scientific exchange, customer engagement,...

  • Medical Lead

    4 weeks ago


    Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full time

    Job Title: Medical Lead - Haematology ExpertJob Summary:The Medical Lead - Haematology Expert will be responsible for representing the affiliate's medical/scientific voice for assigned licensed and pipeline products and relevant therapeutic areas. This role will provide specialist medical/scientific strategic and operational input into core medical affairs...


  • Maidenhead, Windsor and Maidenhead, United Kingdom LEE Fortrea Clinical Research Unit Limited Full time

    At LEE Fortrea Clinical Research Unit Limited, we're seeking a skilled Regulatory Publishing Specialist to drive the publishing of clinical documents within our medical writing team.About UsWe're a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. Our expertise spans a wide...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Lifelancer Full time

    About the RoleWe are seeking an experienced Senior Clinical Trials Development Manager to join our team at Lifelancer. As a key member of our clinical operations team, you will be responsible for leading the development and execution of clinical trials from protocol design to final study report.Key ResponsibilitiesLead and manage integration of all project...


  • Maidenhead, Windsor and Maidenhead, United Kingdom LEE Fortrea Clinical Research Unit Limited Full time

    Are you a medical writing professional looking for a challenging role that combines your expertise with business acumen? We are seeking a skilled Clinical Publishing Expert to join our team at Fortrea Clinical Research Unit Limited.Salary: £60,000 - £80,000 per annum, depending on experience.Job Description:We are a leading global contract research...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Pharmaceutical Corporation Full time

    Senior Medical Liaison and Strategy ManagerWe are seeking a highly experienced Senior Medical Liaison and Strategy Manager to join our team at Pharmaceutical Corporation. This is a challenging opportunity for a seasoned professional with a strong passion for advancing medical science and improving patient outcomes.About the Role:The successful candidate will...


  • Maidenhead, Windsor and Maidenhead, United Kingdom The Rank Group plc Full time

    The Rank Group plc is seeking a seasoned finance professional to drive financial excellence in our dynamic environment.Job DescriptionPlease no agencies. We are looking for a Financial Controls Manager to join our team on an initial 6-month contract.Key Responsibilities:Lead and enhance financial control frameworks, ensuring compliance with regulatory...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Proclinical Staffing Full time

    Proclinical Staffing is seeking an experienced field medical professional to support their medical affairs team.Job DescriptionThe ideal candidate will have a strong background in field medicine and be able to collaborate effectively with cross-functional teams.Support the medical affairs team in various projects and initiatives.Develop and implement...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Proclinical Staffing Full time

    We are looking for a seasoned field medical professional to join our team at Proclinical Staffing.About the RoleThis is a unique opportunity to support our medical affairs team and contribute to the development of field-led projects.Work closely with the medical affairs team to deliver projects and initiatives.Develop and implement effective strategies for...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Sweco UK Full time

    About Sweco UKWe're a leading consultancy in England and Wales, providing expert Building Control services since 1998. Our Corporate Approved Inspector status underscores our commitment to quality and technical excellence.Our team is passionate about delivering successful projects, anticipating regulatory challenges, and working in partnership with clients...