Regulatory Country Strategist

Date Posted: Tuesday, 24th of January 2012

Salary: Negotiable

Start Date: ASAP

Telephone: 01438 870024

Location: Sandwich

Consultant Name: Meera Pattni

Sector: Pharmaceutical

Description

Regulatory Country Strategist

Job purpose:
Manage projects and product related registration strategies in the assigned countries.
Ensure regulatory documentation meet relevant regulatory requirements.
Apply knowledge and interpretation of regulatory requirements in the assigned countries to the drug development process, including promulgation of health authority marketing authorisation dossies to enable efficient and effective registration of medicinal products.

Main responsibilities:
Apply regulatory expertise for assigned countries to enable preparation of high quality documentation and assure compliance with departmental procedures.
Provide input in to the regulatory strategy for the development of products in line with business objectives.
Manage regulatory strategies and plans for assigned countries including review of existing regulatory guidelines and relevant literature.
Coordinate the receipt, distribution and response to regulatory^queries from assigned countries.
Assist in facilitating meetings with regulatory authorities, including preparation of background materials, logistical organisation and guidance of technical specialists.
Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries and ensure that stakeholders are aware of regulatory requirements.
Ensure product strategies, submission and approval time lines, and country registration requirements/guidelines are accurately captured and current in applicable systems/regulatory databases.
Ensure notifications of proposed regulatory changes and approvals are communicated to relevant stakeholders in a timely manner.
Ensure that comprehensive records of communications, country requirements and regulatory status, are maintained.

Person specification:
Life sciences degree.
Appropriate regulatory affairs experience.
Proven ability to manage complex regulatory or drug development issues.
Strategically minded.
Project management skills.

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 CL23571 in all correspondence.

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