Regulatory Affairs Specialist
4 weeks ago
CK Group is seeking a Regulatory Affairs Manager to join a global pharmaceutical company in Harlow on a contract basis for 8 months. The successful candidate will be responsible for ensuring regulatory approvals are secured in a timely manner for on-time launches.
Main Accountabilities:
- Responsibility/ownership of UK/IE assigned Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products.
- Ensure that regulatory post approval 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.
- 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.
- Regulatory strategy development with a focus on bringing innovative solutions to project teams and health authorities.
- Risk assessment and project management skills.
Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
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