[ref. k20837400] Regulatory Affairs Manager

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

Tasks

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

Requirements

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