I am currently working in collaboration with an established niche pharmaceutical company who own one of the world's leading IVF products, which is currently marketed around the world.
It is a dynamic company with a small but growing team. As part of our growth plan, we are now looking to expand our team with a Regulatory Affairs Manager. This is an exciting opportunity, where the right candidate will be working alongside the senior management team on a daily basis, in a supportive environment where you can make a real impact on the company.
- Working alongside regulatory colleagues to transfer over 60 MAs worldwide back to us from the current MA holder.
- Planning, preparation and submission of MA applications, post approval, variations, renewals, post marketing commitment submissions and other ad hoc activities in support of maintaining MAs in the EU, MENA, Africa, Asia and the UK.
- Working alongside the commercial department to determine the viability of entering new markets, and the regulatory requirements, and conditions in these markets.
- Reviewing and submitting artwork and labelling changes, including management of third-party artwork house.
- Building and maintaining effective relationships with external clients/partners alongside partner's regulatory teams.
- Advising on new product development, line extensions and additional indications
- Advising and supporting technology transfer to a new manufacturing site
- Bachelor's degree equivalent or higher qualification within Pharmaceutical or relevant life science
- Strong knowledge of MHRA, EMA regulations, Asia and MENA regulations
- In depth knowledge of EU, Asia & MENA registration procedures- DCP/MRP/National and lifecycle maintenance
- Authoring & preparation of regulatory packages and documents for submissions
- Direct, hands-on experience of MA transfers
- Experience of Change Control, Corrective and Preventive Actions (CAPA) & Deviation procedures
- Experience/knowledge of tech transfer procedures
If this position looks like it could be of interest to yourself or someone in your network, please get in touch ASAP!
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