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 (Apply online only) in all correspondence.

Please note: 

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