My client, an expanding Clinical Research Organisation are currently seeking to recruit a Senior/Director of Regulatory Affairs to join their Regulatory team. This position plays...
To obtain, manage and maintain product Marketing Authorisations and Clinical Trial Authorisations (where applicable) in line with business goals and legal requirements. Under the guidance and supervision of line management, to conduct associated regulatory activities for the specified markets, and to contribute to the implementation and leading of projects.
- In line with defined product responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.
- Provide regulatory input to commercial strategic and operating planning process.
- Attend relevant product team meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary.
- Keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions and ensure compliance of all day to day duties are met by company requirements.
- Use expert knowledge of EU/national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional company colleagues and direct or indirect interactions with external customers.
- Manage and Submit Marketing Authorisation Applications (National/MRP/Decentralised MAA)
- Partner with country operational hubs and strategists to review, co-ordinate and, where required, create necessary technical data to support country submissions e.g. provide national specific module 1 data. Review and approve proposed regulated documents (SPC, PIL, and Labelling) and associated artwork in line with regulations.
- Centralised MAA - Facilitate meeting of local launch dates by ensuring local approval of documents such as Educational Materials. Review and approve proposed regulated documents (SPC, PIL, and Labelling) and associated artwork in line with regulations.
- Manage and Submit MA Variation/Renewal Applications - Prepare agreed Module 1 documents in partnership with above-country operational hubs. Review supporting data and ensure that it complies with local regulatory requirements, agree filing strategy with other business functions as appropriate.
- Prepare agreed Module 1 & Module 2 documents in partnership with above-country operational hubs
- Manage Clinical Trial Approvals - prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including repose to Regulatory Authority queries.
- Life sciences or chemistry graduate to honours level or equivalent
- Master's Degree, Post Graduate Diploma or PhD preferred
- Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs)
- Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products)
- Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferred
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.