Regulatory Affairs Consultant Uk and Ire outside IR35
Posted Today by Hays Life Sciences
£40 Per hour
Outside
Remote
Slough, Berkshire
Summary: The Regulatory Affairs Manager role focuses on managing regulatory submissions and health authority interactions for the UK and Ireland, specifically for a consultancy serving major pharmaceutical clients. This part-time, remote position requires expertise in UK and Ireland registrations, particularly post-Brexit regulations. The successful candidate will ensure compliance with local and EU labelling requirements while coordinating with internal teams. The role is designed for an experienced professional who can quickly adapt to a fast-paced environment.
Key Responsibilities:
- Prepare and submit regulatory applications to the MHRA (UK) and HPRA (Ireland), including variations, renewals, and notifications.
- Manage post-submission queries and liaise with Health Authorities for timely approvals.
- Monitor and interpret local regulatory changes and communicate impacts to internal stakeholders.
- Lead updates to local labelling, including SmPCs, PILs, and packaging texts, ensuring compliance with EU and local requirements.
- Coordinate translations and ensure accuracy with approved English reference texts.
- Collaborate with internal teams to implement labelling changes promptly.
Key Skills:
- Strong background in UK and Ireland regulatory affairs.
- Experience with post-Brexit International Recognition Procedure (IRP).
- Ability to manage multiple regulatory submissions efficiently.
- Excellent communication and collaboration skills.
- Attention to detail in labelling and product information management.
Salary (Rate): £40.00/hour
City: Slough
Country: United Kingdom
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: Mid-Level
Industry: Other
Regulatory Affairs Manager - UK and Ireland outside IR35, part-time, remote
Your new company
This is a rapidly growing Regulatory Affairs consultancy that is looking for an experienced Regulatory Affairs Manager who specialises in UK and Ireland registrations to fulfil a 12-month, remote contract which is outside IR35. They count some of the biggest multinational pharmaceutical companies as clients and continue to provide regulatory solutions that drive success.
Your new role
Regulatory Submissions & Health Authority Interactions: prepare and submit regulatory applications to the MHRA (UK) and HPRA (Ireland), including variations, renewals, and notifications, manage post-submission queries and liaise directly with Health Authorities to ensure timely approvals and monitor and interpret local regulatory changes and communicate impact to internal stakeholders.
Labelling & Product Information Management; Lead updates to local labelling, including SmPCs, PILs, and packaging texts, ensuring alignment with EU and local requirements. As Regulatory Affairs Manager UK and Ire, you will coordinate translations and ensure accuracy and compliance with approved English reference texts and collaborate with internal teams to implement labelling changes in a timely manner.
What you'll need to succeed
This is a fast-paced, busy team, and we are looking for someone with a strong UK and Ire Regulatory background who can hit the ground running. It is essential that those applying for this job have post-Brexit, International Recognition Procedure (IRP) experience.
What you'll get in return
This is a part-time contract job, 20 hours per week. It is fully remote and outside IR35.
What you need to do now
For more information on this Regulatory Affairs Manager UK and Ireland job, please apply. If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.