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Regulatory Affairs Manager

Website Achieva Group Limited

Manager, Life Cycle Management

This position is responsible for post approval changes of Marketing Authorisations, and product life cycle management.

Responsibilities:
Duties inclusive but not limited to the below

  • 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.
  • Provide product & regulatory expertise and clarification on RA requirements for post marketing changes and new product introduction.
  • Provide regulatory support to supply chain, commercial teams, QP, QPPV, Quality 3rd Party contract management as necessary.
  • Contribute to the creation, maintenance and continuous improvement of Regulatory processes, policies and systems.
  • Maintain up to date knowledge of Regulatory and Quality Management requirements, as needed to support the contract manufacture of current products and the introduction of new products.
  • Build good working relationship with CMOs and cross functional teams within the organisation.
  • Supervise assigned team members with respect to management and training.
  • Shall participate in resource planning and recruitment procedure.
  • Ensure compliance with company policies, procedures and training expectations.
  • Performs other appropriate duties, where necessary

 
Required Skills

  • 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.

For further details, please contact Tim Barratt on +44(0)1727 817626 or email tbarratt@achieva.co.uk

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