Ra Officer

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 ensure that the company’s products comply with the regulations of the Medicines and Healthcare Regulatory Agency (MHRA)
- To support Torrent Pharma UK and the Torrent Group’s regulatory department with eCTD submissions by either National, DCP and MRP procedures.
- Assist and coordinate site transfer projects.
- To prepare submission of licence variations and renewals to strict deadlines,
- Partake in the interfacing with regulatory authorities to facilitate the approval of submissions
- Maintain up-to-date records and documentation in relation to Marketing Authorisations.
- Assist in preparation of procedures for relevant regulatory activities, and in preparation and review of procedures for other areas.
- 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.
- 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 in-house, 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.
- To gather all required documentation for the administrative sections of CTD dossier.
- Work collaboratively across organization and contract sites.
- Perform other appropriate duties, where necessary.

Personnel Specifications

Knowledge & Experience
- Experience with communicating with the MHRA at an administrative and strategic level
- Understanding of European / UK regulatory guidelines, regulations and procedures
- Understanding of the timescales of the approval processes within the MHRA
- 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:

- Integrity
- Passion for Excellence
- Participative Decision Making
- Concern for Society & Environment
- Fairness for Care
- Transparency

Torrent Pharma Company Benefits

We are very proud to offer the following in your employment contract package;
- 25 days annual leave (in addition to public bank holidays)
- Private Medical Insurance - Vitality Healthcare
- Life Insurance - Aviva
- Enhanced Employer Pension contribution of 5%
- Choice of 2 days per week to attend our office near Gatwick - hybrid working
- Onsite parking

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