Regulatory Affairs Professional

2 days ago


St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full time

At X4 Life Sciences, we are seeking a highly skilled Regulatory Affairs Specialist to oversee the entire lifecycle of Marketing Authorizations (MAs). This includes maintaining all aspects of MA maintenance, preparing and publishing documentation for Common Technical Documents (CTDs), implementing and communicating MA changes, collaborating with internal teams and external stakeholders, creating patient information leaflets, and managing regulatory files.

Responsibilities:
  • Maintain comprehensive knowledge of regulatory requirements and guidelines to ensure compliance with changing regulations.
  • Develop and implement effective strategies to maintain and improve the company's MA portfolio.
  • Prepare and submit high-quality CTD dossiers to regulatory authorities in a timely manner.
  • Collaborate with cross-functional teams to develop and implement product labeling, packaging, and artwork.
  • Liaise with clients, partners, and regulatory authorities to ensure seamless communication and efficient resolution of issues.
  • Maintain accurate and up-to-date records of MA documents, submissions, and approvals.
Requirements:
  • Bachelor's degree in sciences, engineering, medical/scientific writing, or public health administration.
  • At least 2 years of experience in Regulatory Affairs or a related field.
  • Proven track record of preparing technical documentation for regulatory submissions.
  • Excellent written and verbal communication skills, with the ability to interact effectively with diverse stakeholders.
  • Ability to work independently and manage daily regulatory responsibilities for a product portfolio.


  • St Albans, UK, Hertfordshire, United Kingdom Blackfield Associates Full time

    Global Head of Regulatory AffairsBlackfield Associates are pleased to be partnered with an international presence in the ag chemical industry, who due to growth and strategic vision, have an opportunity for a Head of Regulatory Affairs to lead their Global strategy from the UK Hub. So if you are an experienced Regulatory professional, with cross-functional...


  • St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time

    Job OverviewWe are seeking a skilled Regulatory Affairs Manager to join our team at Achieva Group Limited. This is a fantastic opportunity for an experienced professional to take on a challenging role and contribute to the success of our organization.Key ResponsibilitiesManage post-approval changes of Marketing Authorisations, including variations,...


  • St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time

    About the RoleWe are looking for a talented Regulatory Compliance Expert to lead our regulatory affairs team. The successful candidate will have a strong understanding of GMP, Quality and Regulatory requirements.The estimated salary for this role is £65,000 per annum.


  • St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Achieva Group Limited. The successful candidate will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management.Key ResponsibilitiesManage post-approval filings and life cycle maintenance supplements of Marketing...


  • St Albans, Hertfordshire, United Kingdom Red Door Recruitment Full time

    Job DescriptionA friendly and professional company based in St Albans is looking for a Compliance Manager.The ideal candidate will have at least 3 years of experience in the Compliance sector, preferably in the Investment and Life Protection sectors. They will contribute to the Compliance team to ensure procedures and services delivered adhere to the...


  • St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time

    Job OverviewAchieva Group Limited is seeking a highly skilled Regulatory Affairs Manager to join our team. This role offers a competitive salary of £65,000 per annum.In this position, you will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management across our product portfolio.


  • St Albans, Hertfordshire, United Kingdom Outsourced Professional Administration Limited (OPAL) Full time

    Job SummaryThe Compliance Manager will provide a critical function in ensuring that all relevant activities adhere to regulatory requirements. This includes collaborating with the Head of Compliance and Risk to ensure procedures and services delivered meet regulatory standards.Key ResponsibilitiesProvide Compliance and Risk oversight, including Data...


  • St Albans, UK, Hertfordshire, United Kingdom Planet Pharma Full time

    Our client is a global Pharmaceutical company who have a number of innovative drugs coming through their pipeline in particular within the Neurology Space. They are recruiting for an Associate Director Global Submissions, involving overseeing the efficient operation of managing regulatory submission processes. You would be an expert in the Regulatory Affairs...


  • St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full time

    X4 Life Sciences is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will play a vital role in ensuring the successful launch and maintenance of our products. Your expertise will be crucial in navigating the complexities of regulatory requirements and developing effective strategies to...


  • St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full time

    We are looking for a seasoned Regulatory Affairs Specialist to join our team at X4 Life Sciences. As an essential member of our regulatory department, you will play a critical role in ensuring the successful launch and maintenance of our products. Your expertise will be instrumental in navigating the complexities of regulatory requirements and developing...


  • St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time

    Key ResponsibilitiesAs a Global Regulatory Affairs Specialist, you will be accountable for the management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations.This role offers a competitive salary of £65,000 per annum.


  • St Albans, Hertfordshire, United Kingdom Outsourced Professional Administration Limited Full time

    About the RoleWe are seeking a highly skilled Compliance Risk Specialist to join our team at Outsourced Professional Administration Limited. As a key member of our compliance function, you will play a critical role in ensuring that our business operates within regulatory requirements.


  • St Albans, Hertfordshire, United Kingdom Outsourced Professional Administration Limited (OPAL) Full time

    Compliance DirectorJoin OPAL (Outsourced Professional Administration Limited) in Saint Albans, Hertfordshire, as a key member of our Compliance team. We are seeking an experienced Compliance Director to ensure our company adheres to all relevant regulatory requirements.Responsibilities:Provide a Compliance and Risk service to the firm and employees to ensure...


  • St Albans, Hertfordshire, United Kingdom Pro-Tax Full time

    International Tax Manager RoleAs an International Tax Manager, you will be responsible for managing the EMEA tax affairs, including tax planning strategies, global transfer pricing, and business partnering to provide oversight on tax issues.Manage tax planning strategies to optimize tax efficiencyPartner with business units and senior stakeholders globally...


  • St Albans, Hertfordshire, United Kingdom Outsourced Professional Administration Limited (OPAL) Full time

    Job OverviewOutsourced Professional Administration Limited (OPAL) is seeking a seasoned finance professional to lead its Finance (Co Accts and Recs) and Technical & Dealing Teams. The ideal candidate will have a strong background in financial accounting and financial planning and analysis, with at least 5 years of experience in the financial services...


  • St Albans, Hertfordshire, United Kingdom PRO-TAX RECRUITMENT LIMITED Full time

    International Tax Manager RoleAt PRO-TAX RECRUITMENT LIMITED, we are seeking a highly skilled International Tax Manager to join our team. This is a unique opportunity to develop your technical and commercial skills while working with a globally recognized brand.As an International Tax Manager, you will be responsible for managing tax planning strategies,...

  • EDI Professional

    3 weeks ago


    St Albans, Hertfordshire, United Kingdom Sisk Group Full time

    About Our EDI Partner RoleAt John Sisk & Son, we are committed to fostering a culture of equality, diversity, and inclusion. To support this goal, we are seeking a skilled EDI Partner to join our team.Key Responsibilities:Develop and implement our EDI strategy, ensuring alignment with our company values and objectives.Collaborate with senior leadership to...


  • St Albans, Hertfordshire, United Kingdom Blakemore Recruitment Full time

    Blakemore Recruitment is seeking an experienced and motivated individual to join our team as a Paraplanning and Administration Professional. This role involves supporting Financial Planners to deliver exceptional results and providing administrative support to the team.Main Responsibilities include:To manage client administration tasks, including updating...

  • Senior Tax Manager

    4 weeks ago


    St Albans, Hertfordshire, United Kingdom Taylor Rose Recruitment Ltd Full time

    Tax Specialists at Taylor Rose Recruitment have been instructed on a Private Client Tax Manager opportunity on behalf of our client, a highly progressive firm of Chartered Accountants.Perfect for a CTA Qualified individual seeking a challenging role with an excellent work-life balance and genuine scope to progress.You will be allocated an extensive portfolio...

  • Compliance Manager

    4 months ago


    St Albans, UK, Hertfordshire, United Kingdom Outsourced Professional Administration Limited Full time

    Job Mission: Provide a Compliance and Risk service to the firm and employees of the companies to ensure all relevant activities adhere to all appropriate regulatory requirements. Contribute to the Compliance team in association with the Head and Compliance and Risk to ensure procedures and services delivered adhere to the regulations that apply to a...