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.
- 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.