Regulatory Affairs Manager
My Client an expanding Pharmaceutical company has opened a new vacancy within their Regulatory Affairs team. They are actively looking to recruit a Regulatory Affairs Manager to their team on a permanent basis, for their offices in Berkshire.
Obtaining and maintaining marketing authorisation/clinical trial applications in the EU (with specific reference to the UK/Ireland; but also other territories as required e.g. Australia). To manage and develop the associated activities to maintain these licenses/authorisations, this may be through 3rd party vendors or in- house. To ensure that they comply with its obligations and responsibilities as an IND/MA holder/distributor.
- Submission and approval of Clinical Trial Applications/ Marketing Authorisations in line with the company’s goals and objectives.
- To maintain the Marketing Authorisations of the company's products as appropriate.
- Ensuring that renewal applications/PSURs and variations are prepared, submitted and processed in the correct time scale.
- Ensure any commitments made to or requests for additional information from regulatory authorities are communicated to the relevant internal personnel, especially that safety related issues are communicated to GDSP.
- Ensure that 3rd parties meet agreed time lines.
- Ensure that knowledge of regulatory affairs system and procedures is current.
- Ensure that any changes to the Marketing Authorisations are communicated to the relevant internal personnel, especially that safety related issues are communicated to GDSP.
- To ensure that the correct fees are paid to the regulatory Authority.
- To comply with Health & Safety policies in order to safeguard the health and safety of self and others.
- BSc/BA Degree in related discipline and/or equivalent experience
- 3-5 years experience in regulatory affairs with demonstrated track record of achievement.
- Knowledge and experience of EU and International Regulatory Legislation
- Experience of MRP/DCP and National procedures
- Experience of submitting quality and Safety variations
· For more information regarding this vacancy or a confidential job discussion, please get in touch with Neal Panting. Neal@arc-7.com or +441483 397070