Regulatory Affairs Manager – UK and Ireland outside IR35, part-time, remoteYour newpany
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 pharmaceuticalpanies as clients and continue to provide regulatory solutions that drive success.
Your new roleRegulatory 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 andmunicate 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 andpliance with approved English reference texts and collaborate with internal teams to implement labelling changes in a timely manner.What you'll need to succeedThis 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 returnThis is a part-time contract job, 20 hours per week. It is fully remote and outside IR35.