Regulatory Officer

Recruiter
Key People Limited
Location
Brighton
Salary
£35k - £40k pa
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Generic Responsibilities:
*To comply with all GMP regulations as instructed by management, the Quality department, or as per the current Orange Guide.
*To carry out all duties whilst maintaining good Health & Safety practice with due care to yourself and others.
*To comply with all GSK regulations applicable to the Freeman Building.
*To control and maintain your personal training folder.
*To comply with all Company policies and procedures.
*To carry out any other reasonable request as directed by your Manager or another member of the Management team.
*To follow a code of conduct conducive to a professional environment.

Job Specific Responsibilities:
*Ensure regulatory systems, such as Regulatory Database/trackers are implemented and kept up to date.
*Work with internal & external customers to provide data and accurate regulatory input.
*Prepare & review Labelling/Packaging text. Promotional reviews.
*Ensure compliance with all Company policies and procedures.
Job Specific Responsibilities:
*Ensure regulatory systems, such as Regulatory Database/trackers are implemented and kept up to date.
*Work with internal & external customers to provide data and accurate regulatory input.
*Prepare & review Labelling/Packaging text. Promotional reviews.
*Ensure compliance with all Company policies and procedures.
*Run regulatory projects or regulatory representative on ATL projects meeting timelines and costs of project.
*Understand relevant legislative and regulatory guidance applicable to activities of AT. Particularly new areas like food, veterinary.
*Prepare risk benefit analysis.
*Review updates to the regulatory environment and suggest impact at AT.
*Active involvement in concepts of regulatory strategy.
*Attend industry and RA meetings.
*Member of cross functional teams.
*Communicate with regulatory agencies and document communication.
*Review market request forms.
*Review and sign off change control risk assessments.
*Prepare & review assigned SOPs.
*Train and mentor regulatory team members.
*Contract management and participate in due diligence activities.