Regulatory Affairs Specialist

7 days ago


St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time
Job Overview

We 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 Responsibilities
  • Manage post-approval changes of Marketing Authorisations, including variations, notifications, labelling updates, renewals, and sunset clause management across our product portfolio.
  • Maintain MIA and WDA, including API import registration.
  • Develop and implement filing strategies and manage submission timelines.
  • Identify and remediate compliance gaps as needed.
  • Gather, consolidate, and analyse documentation for regulatory filings.
  • Coordinate and prepare written responses to requests for information from regulatory authorities.
  • Monitor the status of regulatory applications.
  • Review and assess the regulatory impact of change control/requests for the manufacturing, testing, and release of drug substance and drug product.
Requirements
  • Strong understanding of GMP, Quality, and Regulatory requirements.
  • Excellent communication and stakeholder management skills.
  • Proficiency in publishing and compilation of eCTD submissions, eCTD validation, and viewing tools.
  • Maintenance of awareness of changing regulatory requirements.
Compensation Package

The salary for this position is approximately £60,000 - £80,000 per annum, depending on experience.



  • 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 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, 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

    This role is responsible for overseeing the post-approval lifecycle of Marketing Authorisations, ensuring compliance with regulatory requirements.Key ResponsibilitiesThe successful candidate will be accountable for:Maintaining and updating Marketing Authorisation files, including variations, notifications, and labelling updates.Coordinating and preparing...


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

    This role is responsible for managing post-approval changes of Marketing Authorisations and product life cycle management for Achieva Group Limited.Key ResponsibilitiesThe successful candidate will be accountable for the management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations, including variations,...


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

    This role is responsible for overseeing post-approval changes to Marketing Authorisations and product life cycle management across the product portfolio.Key ResponsibilitiesThe successful candidate will be accountable for the management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations, including variations,...


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

    International Tax ManagerSt. li>Do you want to be a tax specialist for a globally recognised brand?Do you want to develop both your technical and commercial skills?A broad, international focused role encompassing planning, M&A, advisory and transfer pricingPartner with business units and senior stakeholders globallyTaking responsibility for the EMEA tax...


  • St Albans, Hertfordshire, United Kingdom Hays Senior Finance Full time

    As a Global Taxation Manager - EMEA Region with Hays Senior Finance, you will play a vital role in dealing with the international tax affairs of this FTSE Listed company. This new role has been created due to expansion and will involve leading the international tax aspects, which includes transfer pricing, M&A, restructuring and more.Your responsibilities...

  • Senior Tax Manager

    3 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...


  • St Albans, Hertfordshire, United Kingdom Premier Engineering Full time

    We are seeking an experienced Quality Assurance Specialist to join our team at Premier Engineering. The ideal candidate will have a strong background in quality management and compliance, with experience in the engineering and manufacturing sector.The Quality Assurance Specialist will be responsible for assessing electrical product compliance and...


  • 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 Churchill Living Ltd Full time

    An exciting opportunity has arisen for an experienced administrative professional to join our expanding team at Churchill Living Ltd. Based in our St Albans office, you will provide comprehensive and confidential administrative support to the Regional Managing Director, ensuring the smooth running of all functions within the administration department.About...


  • St Albans, Hertfordshire, United Kingdom Hays Taxation Full time

    Your new role with Hays TaxationAs a highly skilled International Tax Manager, you will lead the tax aspects of our global group, overseeing and managing international tax affairs across several regions.We are seeking a specialist in international tax to join our team as we continue to grow year-on-year. You will be responsible for:Overseeing tax filings for...


  • St Albans, Hertfordshire, United Kingdom AECOM Full time

    Environmental Excellence in Marine DevelopmentAECOM is seeking a highly skilled Marine Ecologist Senior Specialist to join our team. With an estimated salary of £60,000 - £80,000 per annum, this role offers the opportunity to work on high-profile marine projects across the UK.We deliver comprehensive environmental assessments and strategies for clients,...


  • St Albans, Hertfordshire, United Kingdom Churchill Living Ltd Full time

    An exciting opportunity has arisen for an experienced Administrative Support Specialist to join our expanding team at Churchill Living Ltd. Based in our St Albans office, you will be supporting our growth drive strategy, which aims to double our sales output by 2025.Why choose Churchill Living Ltd?Maximise your earning potential with a competitive basic...