Manager Regulatory Affairs
Manager Regulatory Affairs
Posted on :
17-10-2024
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
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:
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.
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.
Employment Type
4
Company Industry
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
