Associate Director - Regulatory Affairs

Job title : Associate Director - Regulatory Affairs
Location : East London
Job type : Permanent
Salary : Negotiable
Contact name : John Spring
Contact number : +44 (0) 207 255 6650
Contact email : john.spring@secpharma.com
Associate Director - Regulatory Affairs

This position is an excellent opportunity for a Senior Manager or Associate Director level candidate looking for career progression in a global CRO with a broad range of trials across phase I-IV in biotechnology, pharmaceuticals and medical devices. The role is a new position as part of a large-scale growth plan within the corporate RA division.

Salary & Benefits:

Excellent salary and package on offer - full details on request.

Role and responsibilities:
*Manage projects with a focus on facilitating full global regulatory submissions, including: INDs and NDAs (tracking, compiling and maintaining)
*Meeting strict timelines for full regulatory submissions;
*Provide advice and regulatory guidance cross-functionally, ensuring compliance with EMA requirements;
*Interact with EMA and other regulatory agencies globally, including MHRA and FDA;
*Develop regulatory & scientific briefing documents for pre-IND, end of phase II, and pre-NDA meetings with global regulatory agencies

Requires skills and qualifications:

*Life sciences degree and significant regulatory affairs experience;
*Experience in CMCpreferred;
*Experience in dealing with EMA and other global regulatory agencies is highly desired;
*Strong computer skills, project management skills, and a high attention to detail;
*Excellent communication and presentation skills
*Ability to travel up to 25% of the time

To apply for this position and put yourself under immediate consideration, send your CV to john.spring@secpharma.com or call +44 (0) 207 255 6650