Senior Manager, Regulatory Affairs - Neuroscience

Date Posted: Wednesday, 1st of February 2012

Salary: Competitive

Start Date: ASAP

Telephone: 01438 870024

Location: Hertfordshire

Consultant Name: Meera Pattni

Sector: Pharmaceutical

Description

Senior Manager, Regulatory Affairs - Neuroscience

This is a permanent position based in Hertfordshire with a large pharma company.

Job purpose:
You will be responsible for clinical trial submission, scientific advice and regulatory input into clinical and drug development plans for developmental and marketed compounds. You will also be responsible for managing MAA submissions for compounds allocated as well as assisting with new pipeline projects and late stage candidates brought in through in licensing.

Main responsibilities:
Support regulatory strategy and manages timelines and resources to meet project needs.
Take responsibility for the quality and completeness of regulatory submissions for Clinical Trial Applications, amendment updates for NCEs and MAAs.
Responsible for the overall quality and compliance of regulatory submission documents to the appropriate regulatory bodies and act as the day to day contact for regulatory authorities.^
Provide input into clinical and drug development plans.
Provide regulatory input and project management for all variations and other submissions for allocated projects.
Provide assistance in making submissions in emerging markets.
Ensure that EU regulatory strategy is addressed and any required submissions are made to agreed timelines.
Organise Regulatory Agency meetings and accompanying briefing documents.
Provide EU regulatory input into IPTs.
Take lead in interacting with regulatory agencies.

Person specification:
Life sciences degree.
Regulatory experience in R&D.
In depth knowledge of EU Clinical Trials Directives.
Extensive experience of IMPDs, submission of CTAs and EudraCT databases.
Extensive experience of the Drug Development process.
Experience of providing input into clinical development plans.
Through knowledge of and experience of submissions made through MRP, DCP and Centralised Procedure.
Experience of writing Agency Briefing Books.

CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL23624 in all correspondence.

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