Description
I am searching for an experienced Regulatory Affairs consultant with Generics experience to start work as soon as possible, on a 6 month contract in a rapidly growing Generics manufacturer and distributor.
The company is based in Hampshire, and very competitive rates are being offered for the successful candidate.
There is 1 member of the Regulatory team currently on site at the moment, effectively they are building a brand new Regulatory team, which is a fantastic opportunity to gain hands on experience & make a big impact.
The role will include:
-Production and review of Design Dossiers, Technical Files and Product Master Files
-Preparation of regulatory submissions for product approvals/registrations
-Participation in Quality Audits and supporting QA manager in ensuring readiness for audits
-Communicating with outside agencies/regulatory bodies
For this role you will ideally have the following experience:
-Involved in the regulatory approval of promotional material (eg copy approval against ABPI codes of practice)
-Prepared and submitted NEES submissions to the IMB and MHRA
-Preparation and submission of National and MRP Type IA (immediate notification and annual reports), Type IB, Type II Variation packages via grouping and work-sharing
-Involved in preparing responses to RFIs & liaising with Assessors
-Submission of Renewals
-Experience of working with the MHRA
-Budgeting: Maintaining all regulatory activities within department budget along with providing finance with regular updates
-Writing and reviewing SOPs
-Regularly update EMC and IPHA websites following changes made to SPCs and PILs
-Coordinated user testing of UK PILs
For more information on this fantastic opportunity, please reply to this advert or call Richard Williamson.
Lawrence Harvey is acting as an Employment Business in regards to this position.