Job Title: Regulatory Affairs Manager
Location: Harlow, UK (Hybrid: 2 days on-site)
Contract Duration: 8 months (Inside IR35)
Pay Rate: £32 - £37 per hour
Work Structure: Monday to Friday, 7:30 AM – 3:30 PM
Our client, a leading pharmaceutical company, is seeking an experienced Regulatory Affairs Manager to manage regulatory activities for the UK and Ireland, focusing on Marketing Authorisation Applications (MAAs) for New Chemical Entities (NCEs), Generics/Hybrids, medical devices, biosimilars, and OTC products. The role involves overseeing the full lifecycle of product approvals, from submission to launch, ensuring regulatory compliance and timely approvals.
Key Responsibilities:
- Lead and manage regulatory submissions and strategies for UK/IE MAAs.
- Ensure timely product approvals and manage post-approval obligations.
- Collaborate with cross-functional teams to support product development and in-licensing initiatives.
- Liaise with MHRA and HPRA to resolve regulatory challenges and ensure compliance.
- Mentor and train team members while staying updated on regulatory changes.
What We’re Looking For:
- Degree in Pharmacy, Chemistry, or Life Sciences.
- Strong background in Regulatory Affairs within the pharmaceutical industry, with significant experience in new submissions and post-approval activities.
- Demonstrated experience working with MHRA and HPRA.
- Experience in CTAs, paediatric investigation plans, and orphan designations is highly desirable.
- Proven expertise in regulatory strategy development and project management.
Required Knowledge:
- Detailed understanding of CMC data requirements, clinical data, and lifecycle management for pharmaceutical products.
- In-depth knowledge of medical device registration and Brexit-related MHRA requirements.
If you are a motivated regulatory professional looking for a dynamic, friendly team and an opportunity to contribute to meaningful pharmaceutical projects, this could be the role for you!
How to Apply:
To apply, please submit your CV outlining your qualifications and experience relevant to this role.
Please note: You must be able to work in the UK without restriction or sponsorship to be eligible for this role. If you are interested in finding out more about this role or others, please contact Jada Kirlew at jkirlew@i-pharmconsulting.com or call: +44 (0)20 7551 0727 (UK) / +31 208 089 982 (NL)
