Regulatory Affairs Manager
- Regulatory Affairs
Regulatory Affairs Manager - Permanent
Hemel Hempstead, UK
Extremely Competitive salary and benefits package
Reference number- JO-1812-421013
An opportunity has arisen for a Regulatory Affairs manager with an eye for detail to come and make an impact in a market leading company that has a huge success within Pharmaceuticals with a worldwide prominence.
Coming from a strong Regulatory background, you will be expected to:
-Work alongside regulatory colleagues to transfer over 60 MAs worldwide back to the company from the current MA holder.
-Plan, prepare and complete the submittal 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.
-Work alongside the commercial department to determine the viability of entering new markets, and the regulatory requirements, timelines and conditions in these markets.
-Review and submit artwork and labelling changes, including managing of third-party artwork house.
Managing external pharmacovigilance and medical information 3rd party agent.
-Build and maintain effective relationships with external clients/partners alongside partners regulatory teams.
-Advise on new product development, line extensions and additional indications.
-Liaise with regulatory authorities for advice and guidance when necessary, and resolve issues to achieve the best possible outcome for the business.
-Take full responsibility and ownership of ensuring that all relevant electronic systems are updated and maintained in alignment with regulatory submissions and commitments.
-Advise and support technology transfer to a new manufacturing site.
As a successful applicant, you must have:
-A Bachelors degree equivalent or higher qualification within Pharmaceutical or relevant life science
- Extensive knowledge of MHRA, EMA regulations, Asia and MENA regulations
-In depth knowledge of EU, Asia & MENA registration procedures- DCP/MRP/National and lifecycle maintenance.
- A proven track record of successfully authoring & preparing regulatory packages and documents for submissions
-Direct, hands-on experience of MA transfers
- Experience reviewing/annotating and approving artworks and labelling
-Experience working with government agencies and trade organisations to clarify and resolve regulatory matters.
If this role is of interest to you, and you would like to have a confidential more in depth chat regarding the position then please give me a call on 01189522797.
Alternatively, feel free to email me your CV to firstname.lastname@example.org for immediate consideration.
If this role is not quite right, no worries at all. If youre interested in hearing about other great career opportunities, then please still get in touch as there are numerous Regulatory requirements at the moment. Additionally, if you know someone that may be interested in this role then we reward 250 worth of vouchers for every successful placement so please let me know!