Manager Regulatory Affairs

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.