Regulatory Affairs Specialist for Global Pharmaceutical Company
8 hours ago
We are seeking a skilled Regulatory Affairs Manager to join our client, a global leader in generics and biopharmaceuticals, in Harlow. This role offers the opportunity to work on regulatory submissions, post-approval obligations, and product development.
Key Responsibilities- Ownership of UK/IE Marketing Authorisation Applications for new products
- Deliver new submission work plans for allocated products
- Secure timely regulatory approvals for on-time launches
- Fulfill regulatory post-approval obligations to ensure compliance
To be successful in this role, you will have experience in regulatory affairs, with demonstrated skills in contact, relationship, and working with health authorities. Your background should include regulatory new submission and post-approval submissions for various dosage forms.
- A working knowledge of CTAs, paediatric investigation plans, and orphan designations
- Risk assessment and project management skills
This is an excellent chance to bring your expertise to a dynamic team and contribute to the company's mission to improve patients' lives worldwide.
Salary: £30.18 per hour (PAYE). This rate reflects the location and industry standards.
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