Description
Regulatory Affairs Manager -LondonAs the Regulatory Affairs Manager you will be tasked with handling global Regulatory Affairs maintenance work on licensed products globally.
Candidates will have the following responsibilities:
- Plan, manage and execute regulatory activities on products such as submission of variations, renewals, and Marketing Authorisation Applications in further countries
- Drive submissions through National, MRP, DCP and CP (CP and National are essential for this position)
- Interface with regulatory counterparts in affiliate companies as well as internal departments to support regulatory activities on assigned products
- Plan and coordinate dossier preparation and review of submission documents
- Review of PSURs and coordination of PSUR submission
- Act as point of contact for EU Regulatory Authorities
Experience Necessary:
- Experience in global Regulatory Affairs maintenance work
- Extensive National and Centralised Procedure experience
- Degree in pharmacy/life science
- Experience working with European Regulatory Authorities
- Proven European regulatory submissions capability, in particular in post authorisation activities
- Detailed knowledge of EU regulations and guidelines, in particular on submissions post approval
- Knowledge of eCTD
This is a permanent full-time position based inLondonwith a leading global pharmaceutical company.
This position offers a salary of circa £57500 with excellent benefits.
Please contact Alan Lloyd on for more information on this excellent position.
To find out more about Real please visit www.realstaffing.com