CK Group are recruiting for a Regulatory AffairsManager, to join a global pharmaceutical company, based in Harlow,on a contract basis for 8 months(maternity leave cover).
Salary:
30.18 perhour PAYE.
RegulatoryAffairs ManagerRole:
MainAccountabilities:
* Responsibility/ownershipof UK/IE assigned Marketing Authorisation Applications for NewChemical Entities, Generics/Hybrids, devices, biosimilar and OTCproducts.
* Deliver new submission work plancommitments for all allocated products.
* Ensurethat regulatory approvals are secured in a timely manner foron-time launches.
* Ensure that regulatory postapproval regulatory obligations are fulfilled to ensure compliance,deliver on time launches and maintain continuity ofsupply.
* Provide/contribute to regulatorystrategies, guidance and support for product development toapproval for local co-development initiatives and local in-licenseof new products.
YourBackground:
* Experiencein regulatory affairs inpharmaceuticals.
* Demonstrated experience ofcontact, relationship and working with MHRA andHPRA.
* Substantial regulatory new submission andpost approval submissions experience for a wide range of dosageforms including generics, new chemical entities, devices and OTCproducts.
* A working knowledge and experience inCTAs, paediatric investigation plans and orphandesignations.
* Regulatory strategy developmentwith a focus on bringing innovative solutions to project teams andhealth authorities.
* Risk assessment and projectmanagement skills.
Company:
Ourclients aim is to be a global leader in generics andbiopharmaceuticals, improving the lives of patients across theworld.
Location:
Thisrole is based at our clients site in Harlow.
Apply:
It is essential that applicants hold entitlement to work in the UK.Please quote job reference 107 899 in allcorrespondence.
Pleasenote:
This role may be subjectto a satisfactory basic Disclosure and Barring Service (DBS)check.