Senior Regulatory Affairs Associate

Recruiter
Austin Fraser Limited
Location
London (Greater)
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Senior Regulatory Affairs Associate

East London

Competitive Salary + Benefits Package

I am working with a leading U.K Pharmaceutical Company specialising in manufacturing drug products in 4 areas, due to growth they are looking to bring in a Senior Regulatory Officer who has extensive experience working with CMC.

This company looks to be European leaders for treatment in addiction, pain & critical care, not only this, they have a presence in regions such as China, Canada, Middle East, Africa & APAC.

Responsibilities:

* Actively working with the NPD group on the CMC regulatory strategy for assigned development projects
* Preparation of CMC regulatory strategies for expediting new EU registrations and complex post-approval changes
* Project managing high-quality CMC documentation for new product development
* Leading and managing the day-to-day CMC activities with minimal supervision
* Assisting the regulatory team in updating and writing of CTD Module 3
* Writing responses to CMC questions and updating relevant CMC Module 3 documentation for any ongoing procedures
* To lead, plan, create and compile high-quality CMC documentation for new registrations in EU and International Markets
* Liaising with relevant departments to make sure all regulatory needs are met

Requirement:

* Relevant Life Science Degree
* 3 years CMC experience
* Post-approval experience
* Proven record in building relationships with key individuals

If you feel this role isn't right for you however you know someone who could be interested and we end up placing that individual, we offer a £200 referral fee.

Due to the nature of this role, I have been receiving a large volume of applications, if this is of interest then please get in touch asap.

Please note: Candidates must be eligible to work in the U.K and have had to come from a Regulatory Affairs background working in either the Pharmaceutical/Biotech/CRO/Consultancy environment.