Regulatory Affairs Specialist
4 weeks ago
Regulatory Affairs Manager Role:
Responsibility/ownership of UK/IE assigned Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC 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.
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.
This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
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