Regulatory Affairs Director

1 day ago


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

**Job Title:** Regulatory Affairs Manager

About the Role

This position is responsible for managing post-approval changes of Marketing Authorisations and product life cycle management. We are seeking a highly skilled and experienced professional to join our team.

Key Responsibilities
  • Accountable for management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations like variations, notifications, labelling updates, renewals, sunset clause etc across product portfolio.
  • 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.
  • Review and assess the regulatory impact of change control/requests for the manufacturing, testing and release of drug substance and drug product.
Requirements
  • Understanding of GMP, Quality and Regulatory requirements.
  • Communicative and able to work with a range of stakeholders, at all levels, both internally and externally.
  • Proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools.
  • Maintaining an awareness changing regulatory requirements.
What We Offer

We offer a competitive salary of £65,000 - £75,000 per annum, depending on experience.



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

    About the Job:We are seeking a Regulatory Affairs Director to join our team at CV Library. As a key member of the financial services business, you will be responsible for providing compliance and risk services to ensure all relevant activities adhere to regulatory requirements.The successful candidate will report directly to the CFO and manage a small team....


  • 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 successful candidate will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management across our product portfolio.Key Responsibilities:Post-Approval Filings: Accountable for the management of post-approval...


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

    Job Title: Regulatory Affairs Specialist Achieva Group Limited is seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management.About the RoleThe successful candidate will be accountable for the management of...


  • 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

    Job OverviewAchieva Group Limited is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory department, you will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management.The ideal candidate will have a strong understanding of GMP, Quality, and Regulatory...


  • 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

    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 RoleThis position is responsible for post-approval changes of Marketing Authorisations, and product life cycle management. We are looking for someone with...


  • 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 Blackfield Associates Full time

    Blackfield Associates is looking for an experienced Agricultural Chemicals Team Director to lead their regulatory team and drive the company's growth in the crop treatment and agricultural chemical market. The successful candidate will be responsible for developing and implementing regulatory strategies, managing regional registration activities, and...


  • 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.


  • 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 Blackfield Associates Full time

    Job DescriptionWe are looking for a highly skilled Senior Manager to lead our Regulatory Affairs team. As Regulatory Team Lead, you will be responsible for developing and implementing global regulatory strategies across our crop treatment and agricultural chemical portfolio.The successful candidate will have a deep understanding of the EU regulatory process...


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

    Regulatory Affairs Policy Expert WantedWe are seeking an experienced Senior Manager Regulatory Policy to join our team at Blackfield Associates. As a senior member of our Crop Treatment and Agricultural Chemical company, you will be responsible for leading a team of Product Scientists and establishing a clear regulatory strategy for our portfolio.Your Key...


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

    Achieva Group Limited is seeking an experienced Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management, as well as developing and managing submission timelines for regulatory filings.Job...


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

    **About Achieva Group Limited**Job SummaryThis is a challenging and rewarding role that requires a high level of expertise in regulatory affairs. The successful candidate will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management.ResponsibilitiesDeveloping and implementing filing strategies for...


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

    About the RoleHays Taxation is seeking a seasoned International Tax Director to lead our client's international tax affairs. As a key member of the senior management team, you will be responsible for driving the company's tax strategy and ensuring compliance with all relevant regulations.The successful candidate will have extensive experience in...


  • 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...