| Reference |
IDSS000101DP |
| Title |
Regulatory Affairs Manager |
| Description |
Our client is focused on supporting biotech and pharmaceutical
companies at every stage of the product lifecycle, from
first-into-human studies to product launch and beyond.
This is a
new role due to continued expansion and offers a first class
opportunity to excel in a position that will grow with the business.
Responsible for conducting a range of EU regulatory activities for clients, key tasks will include:
-
Preparation and/or review of IMPDs to ensure relevant data are included and presented in a clear manner
-
Working with Clinical colleagues to ensure all other documents required
for submission of CTAs to National Competent authorities are available
in an appropriate time frame and meet regulatory requirements
-
Preparation of responses to any issues that arise on CTA applications
-
Preparation of EU Scientific advice briefing books
-
Managing the logistical aspects of agency meetings and submissions for Scientific Advice and Orphan Drug Designations
-
Contributing to the preparation of MAAs
Candidate Requirements
-
At least a B.Sc in a relevant discipline with a preference for a Pharmacist
-
Minimum of 3 years regulatory experience or equivalent knowledge preferably gained in a CRO
-
Scientific writing experience ie experience of writing documents like an IMPD
-
Hands on experience of CTAs across multiple countries and EU Scientific advice procedure
-
Experience with, and interest in, CMC aspects of regulatory applications
-
Excellent IT skills preferably with experience of dossier publishing tools
|
| Salary |
Excellent package offered |
| Location |
Europe, UK, Hertfordshire |
| Contact |
david.proudfoot@id-ss.com |