CK Group are recruiting for a Regulatory AffairsManager, to join a company in the Pharmaceutical industry, at theirsite based in High Wycombe, on a contract basis to the end of March2025.
Salary:
Hourly 61.00 per hour PAYE or82.00 per hour Umbrella.
Regulatory Affairs ManagerRole:
Managementof post-approval activities for specified OTCproducts
* Supports the EMEA RegulatoryAffairs team for post-approval activities for MRP/DCP productsacross EEA and coordinate worksharing (WS) procedures for CMC andnon-CMC variation, when WS isappropriate.
* Development of regulatorystrategies, preparation of regulatory applications and supportmaintenance activities for MRP/DCPproducts.
* Supports the team with regulatoryactivities for European procedures (Decentralised, MutualRecognition, WS) as appropriate.
* Supports theteam with regional regulatory strategies in line with business planfor post-approval activities.
* Supports the teamto complete identified regulatory activities to ensure allregulatory obligations and business objectives aremet.
* Prepares and compiles regulatorysubmissions (Variations, renewals, PSUSA etc.), responses toRegulatory Agency (RA) questions and other correspondence inaccordance with EU regulations andguidelines.
* Ensure Marketing Authorisations aremaintained andrenewed.
YourBackground:
* Lifesciences or chemistry graduate to honours level orequivalent.
* Works with minimal supervision toplan, conduct, and manage regulatory submissions for Europeanprocedures and multiple projects to meet department and companyobjectives.
* Work with minimal supervision todetermine and develop approaches to solutions with technicalguidance on a variety of problems of moderate scope andcomplexity.
* Project management, understandingof regulatory environment, interaction with the RegulatoryAuthorities (as appropriate), commercial / strategic awareness,implement regulatory strategy, managing and maintaining MarketingAuthorisationsetc.
Company:
Our client is the largest and most broadly-based healthcarecompany. They strive to improve access and affordability, createhealthier communities, and put a healthy mind, body and environmentwithin reach of everyone, everywhere.
Location:
This role is hybrid workingwith 2/3 days per week based in High Wycombe.
Apply:
It is essential that applicants hold entitlement to work in the UK.Please quote job reference 107 872 in allcorrespondence.
Pleasenote:
This role may be subjectto a satisfactory basic Disclosure and Barring Service (DBS)check.