Job Description
Our client, a global pharmaceutical company which develops a portfolio of prescription generic and branded pharmaceuticals within the CNS, Neurology and respiratory areas.
As Regulatory Affairs Manager, you will:
* Preparation, submission, and management of variation applications to agreed timelines
* Manage and submit Renewals and PSURs in line with specified timelines.
* Preparation, submission, and management of approvals of National, Mutual Recognition, Decentralised and Centralised Procedure applications in the region- MRDCP
* Preparation and maintenance of the product information SmPC/PIL.
* Management of all regulatory activities related to the UK and EU markets (including artwork approvals, maintenance of Manufacturer’s / Importer licence (MIA) etc.)
* Record data in relevant regulatory database.
* Ensure development of procedures for compliance purposes
To be considered for the role of Regulatory Affairs Manager, you will have the following experience and skills:
* Educated to degree level in relevant Life Sciences field or equivalent is essential.
* An in-depth understanding and experience of EU regulatory requirements including marketing authorisation submissions and maintenance activities on a European level.
* Experience working in a UK affiliate for Generic pharma is essential
* Experience in other non-EU markets in the region is an advantage.
* Able to demonstrate working cross functionally, such as implementing strategy
* IT skills at an advanced level (Excel and other MS Office tools, various Regulatory Affairs Information Systems such as eCTD publishing tools, databases and tracking systems, CESP, MHRA portal, etc.)
* Able to work hybrid, with weekly presence in the Slough office
* Have the right to work without the need for sponsorship
* Only applicants who have worked in Generic Pharma on a permanent basis will be considered.
* Not open to Contractors / Freelancers.
This is a permanent position, which alternates between 3 days and 2 days per week onsite.
For more information or to discuss this opportunity, please contact Rob Carnell at Blackfield Associates.