Regulatory Affairs Assistant - Crawley, United Kingdom - Torrent Pharma UK Ltd

Torrent Pharma UK Ltd

Verified Company

Crawley, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Purpose

Key

Responsibilities:

Please note; this list is not exhaustive and responsibilities may include any other reasonable requests in line with your skill set_
To gather all required documentation for the administrative sections of CTD dossier.
Assist in regulatory tracker and folder management.
Submit sunset clause and renewals.
Perform product information compliance activities for the entire product life cycle.
Check, approve and release labelling/ packaging documents for contract manufacturing sites and own site.
Work closely with inhouse, 3rd party designers and contract sites for packaging artwork development and updates.
Support and maintain labelling systems, process and related activities as required.
Identify any compliance issues or gaps and support Line Manager in evaluating business impact and corrective actions.
Prepare regulatory documents including RFI response and submit to the Agency/Authority.
Work collaboratively across organization and contract sites.
Ensure compliance with company policies, procedures and training expectations.
Perform other appropriate duties, where necessary.
To support Torrent Pharma UK and the Torrent Group's regulatory department with eCTD submissions by either National, DCP and MRP procedures.
To support in PV related activities.
To comply with office policies and guidelines.
Maintain regulatory files/database and chronologies in good order. Maintain system for tracking changes in documents submitted to agencies or partners.
Work closely with inhouse,3rd party designers and contract sites for packaging artwork development and updates.
Support and maintain labelling systems, process and related activities as required.
Work collaboratively across organization and contract sites.
Perform other appropriate duties, where necessary.

Personnel Specifications

Knowledge & Experience

Previous experience working with regulatory agencies advantageous
Understanding of European regulatory guidelines, regulations and procedures
Understanding the company Regulatory Affairs SOP's
Understanding of pharmacovigilance practices and procedures

Personal Skills

Ability to manage conflicting priorities
Excellent communication skills
Strong interpersonal skills
Accurate
Methodical
Attention to detail
Proactive

Torrent Pharma Values and Behaviours:
All employees at Torrent Pharma are expected to demonstrate and embrace our Values, Behaviours and Ways of Working.

Our Values: