Regulatory Submissions Technical Advisor

Job title : Regulatory Submissions Technical Advisor
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
Regulatory Submissions Technical Advisor

This position is an excellent opportunity an ambitious RA professional with an interest and a good track record in clinical operations 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:
*Offer regulatory submissions strategic guidance, counselling and advice to the Regulatory Submissions Manager and their project teams as well as relevant Sponsors, ensuring the submissions are compliant with appropriate regulations
*Preparation and review of core trial documents for compliance with relevant regulations and guidelines and for clinical trial suitability;
*Reviewing of pertinent guidance and regulations to ensure development of proactive solutions to any encountered regulatory issues;
*Independent interaction with specific Sponsors, global regulatory bodies company colleagues in other departments
*Presentation of information during bid defences, meetings and audits

Requires skills and qualifications:

*Minimum of a Bachelor's degree in Life Sciences - advanced degrees such as Master's or PhD preferred
*Strong clinical research experience, ideally in a CRO environment or similar
*Excellent understanding of regulatory documents, guidelines and legislation
*Proven ability to review regulatory guidance and development of solutions to regulatory issues
*Experience in the review and creation of core regulatory documents
*Strong communication and presentation skills both orally and in writing
*Ability to independently interact with regulatory agencies from national to global scale

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