Manager Regulatory Affairs

3 weeks ago

Harlow Essex, United Kingdom CK Group Full time €30
CK Group are recruiting for a Regulatory Affairs Manager, to join a global pharmaceutical company, based in Harlow, on a contract basis for 8 months (maternity leave cover).

 


Salary:

£30.18 per hour PAYE.

 


Regulatory Affairs Manager Role:

Main Accountabilities:
  • Responsibility/ownership of UK/IE assigned Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products.
  • Deliver new submission work plan commitments for all allocated products.
  • Ensure that regulatory approvals are secured in a timely manner for on-time launches.
  • Ensure that regulatory post approval regulatory obligations are fulfilled to ensure compliance, deliver on time launches and maintain continuity of supply.
  • Provide/contribute to regulatory strategies, guidance and support for product development to approval for local co-development initiatives and local in-license of new products.
Your Background :
  • Experience in regulatory affairs in pharmaceuticals.
  • Demonstrated experience of contact, relationship and working with MHRA and HPRA.
  • Substantial regulatory new submission and post approval submissions experience for a wide range of dosage forms including generics, new chemical entities, devices and OTC products.
  • A working knowledge and experience in CTAs, paediatric investigation plans and orphan designations.
  • Regulatory strategy development with a focus on bringing innovative solutions to project teams and health authorities.
  • Risk assessment and project management skills.
 

Company:

Our clients aim is to be a global leader in generics and biopharmaceuticals, improving the lives of patients across the world.


 

Location:

This role 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 all correspondence.



Please note:  

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.

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