Regulatory Affairs Lead

2 weeks ago


St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time
Achieva Group Limited is seeking a highly skilled Regulatory Affairs Manager to join our team. The ideal candidate will have a strong understanding of GMP, Quality and Regulatory requirements.

About the Role

This position is responsible for post-approval changes of Marketing Authorisations, and product life cycle management. We are looking for someone with excellent communication skills who can work with various stakeholders, both internally and externally.


Key Responsibilities
  • Maintenance of MIA and WDA including API import registration.
  • Filing strategy and managing submission timelines.
  • Identifying and remediating compliance gaps if any.
  • Gather, consolidate, analyse documentation and submit regulatory filings.
  • Coordinate and prepare written responses to requests for information from regulatory authorities.
  • Monitor status of regulatory applications.

Requirements

The successful candidate will have:

  • Proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools.
  • Maintaining an awareness changing regulatory requirements.

We offer a competitive salary of £65,000 - £80,000 per annum, depending on experience.



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

    Regulatory Affairs Engineer: We are seeking an experienced Regulatory Affairs Engineer to join our team at Premier Engineering. The successful candidate will have expertise in regulatory affairs and compliance within the engineering and manufacturing sector.About the Role: As a Regulatory Affairs Engineer, you will be responsible for ensuring that all...


  • 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...


  • 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 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

    Aircraft RegulatoryAbout the Role: Achieva Group Limited is seeking a highly skilled Regulatory Affairs Manager to join our team.Job Description: The successful candidate will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management. This includes accountable management of post-approval filings and life...


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

    About the RoleThis exciting opportunity is ideal for a seasoned Quality professional looking to take on a leadership position in a growing pharmaceutical manufacturer.Responsibilities:Continuously review and improve the quality management system to ensure compliance with regulatory requirements.Verify product quality and ensure adherence to GMP...


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

    Achieva Group Limited is a dynamic company that is always looking for ways to improve. We are seeking a highly skilled Regulatory Affairs Manager to join our team and help us achieve our goals. The ideal candidate will have a strong background in Regulatory Affairs and excellent communication skills.About the RoleThis position is responsible for...


  • 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.

  • Regulatory Team Lead

    3 weeks ago


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

    Our client, a leading crop treatment and agricultural chemical company have a requirement for a Regulatory Team leader to lead a team of Product Scientists and establish a clear regulatory strategy for the company portfolio. As Regulatory Team Lead, you will:Lead the product science team working across the product portfolio Lead implantation of Global...


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

    As a Regulatory Affairs Manager at Achieva Group Limited, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining the quality of our products. Your primary responsibilities will include managing post-approval changes of Marketing Authorisations and product life cycle management, as well as developing and managing...


  • 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

    Achieva Group Limited is a leading company in the industry, and we are seeking a highly skilled Regulatory Affairs Manager to join our team. The ideal candidate will have a strong background in GMP, Quality and Regulatory requirements, as well as excellent communication skills.About the RoleThis position is responsible for post-approval changes of Marketing...


  • 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 Achieva Group Limited Full time

    Achieve Excellence in Regulatory AffairsWe are seeking a talented individual to join our Achieva Group Limited team as a Post-Marketing Change Coordinator.Key Responsibilities: The ideal candidate will be accountable for management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations. This includes tasks such as...


  • 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...

  • Senior Counsel

    2 days ago


    St Albans, Hertfordshire, United Kingdom Tanner Pharma Group Full time

    Job Description:We are seeking a Senior Counsel to join our legal and compliance team in St Albans. As a Senior Counsel, you will be responsible for advising on complex legal issues, drafting and negotiating international commercial contracts, and enforcing ethics and compliance requirements across our regional offices.About You:To be successful in this...


  • St Albans, Hertfordshire, United Kingdom CV Library Full time

    About the Job:We are looking for a highly motivated and organized individual to lead our compliance and regulatory activities, improving product and process reliability, and ensuring environmental sustainability.


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

    A career-defining opportunity awaits with Hays Taxation as an International Tax Manager LeadYou will play a critical role in shaping our global tax strategy, working closely with senior management to drive growth and success. Key responsibilities include:Leading the tax function across EMEA, US, Australasia, and moreProviding expert advice on transfer...


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

    Job DescriptionWe are looking for a seasoned Quality professional to join our team as Head of Quality. In this role, you will be responsible for:Overseeing and continually reviewing the quality management system to identify improvements and address deficiencies;Verifying that products meet regulatory requirements;Reviewing third-party audit reports and...