Regulatory Affairs Manager Position
2 weeks ago
We are seeking a highly skilled Regulatory Affairs Manager to join our team at CK Group. The successful candidate will be responsible for ensuring regulatory approvals are secured in a timely manner for on-time launches. This will involve delivering new submission work plan commitments for all allocated products and ensuring regulatory post approval regulatory obligations are fulfilled to ensure compliance, deliver on time launches and maintain continuity of supply.
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.
Requirements:
It is essential that applicants hold entitlement to work in the UK. Please note that this role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
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