Consultant, Regulatory Affairs - Lifecycle

Date Posted: Monday, 23rd of January 2012

Salary: Competitive

Start Date: ASAP

Telephone: 01438 870024

Location: Hertfordshire

Consultant Name: Meera Pattni

Sector: Pharmaceutical

Description

Consultant, Regulatory Affairs - Lifecycle Management

This role is part time (2 days per week) for 6 months.

Job purpose:
You will be responsible for maximising product lifecycle management and licence maintenance for current marketed products by ensuring that submissions for maintenance activities are prepared for a high standard. You will also provide support for compounds in development, by ensuring timely submissions of documents related to clinical trials and providing advice on EU clinical trial regulatory requirements.
You will also be required to assist with other regulatory submissions including PIPs, Scientific Advice briefing documents, MAA documentation and annual reports.

Main responsibilities:
Manage and coordinate submission activities for assigned products, for example CTA and Product Licence Variations.
Accountable for the quality and compliance of regulatory submissions for assigned projects.
Provide input into productlifecycle plans and maintains licences for marketed products.
Become the day to day contact point with regulatory authorities for communications relating to proposed/pending submissions.
Assists with the creation and review of SOPs.
Interact with external stakeholders regarding regulatory issues.

Person specification:
Life sciences degree.
Strong EU regulatory experience and a good understanding of US processes.
Good knowledge of EU Clinical Trials Directives, Pediatricregulations, Scientific advice/protocol assistance processes.
Experience of IMPDs, CTAs and EurdaCT databases.
Experience within oncology desirable.
Excellent communication skills.

CK Clinical is an Equal Opportunities employer and welcomesapplications 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 CL23555 in all correspondence.

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