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 for 6months.
Salary:
Hourly rate up to 62.93 PAYE(inside IR35).
Regulatory Affairs ManagerRole:
* Management of aproduct or specified products within a therapy area for OTCMedicines, Cosmetics, Medical Devices and/or FoodSupplements.
* Development of regulatorystrategies, preparation of regulatory applications and supportmaintenance activities within relevant therapyarea.
* Prepares and compiles regulatorysubmissions (Marketing Authorisations, Reclassifications etc.),responses to Regulatory Agency questions and other correspondencein accordance with EU regulations andguidelines.
* Sign off of packaging material,leaflets, SmPCs and advertising material (as appropriate) to ensureregulatory compliance for submissions via the relevant internalsystems.
* Ensure Marketing Authorisations aremaintained andrenewed.
YourBackground:
* Lifesciences or chemistry graduate to honours level orequivalent.
* Experience of the plan, conduct,and management of regulatory submissions and multiple projects tomeet department and company objectives.
* Able todetermine and develop approaches to solutions with technicalguidance on a variety of problems of moderate scope andcomplexity.
* Must have experience of OTCmedicines. Useful if you have experience of cosmetics, medicaldevices and/or food supplements but notessential.
* Project management, understanding ofregulatory environment, interaction with the Regulatory Authorities(as appropriate), commercial / strategic awareness, implementregulatory strategy, managing and maintaining MarketingAuthorisations etc.
Company:
Ourclient is the largest and most broadly-based healthcare company.They strive to improve access and affordability, create healthiercommunities, and put a healthy mind, body and environment withinreach of everyone, everywhere.
Location:
This role is hybrid workingwith 1-2 days per week based at our clients site in High Wycombe.
Apply:
It is essential that applicants hold entitlement to work in the UK.Please quote job reference 105146 in allcorrespondence.
Pleasenote:
This role may be subjectto a satisfactory basic Disclosure and Barring Service (DBS)check.