Regulatory Affairs Assistant Crawley, West Sussex, South East England, England
Job description
Purpose
To maintain all UK Product licences in accordance with the UK regulatory guidelines (MHRA), ensure all UK licence applications are submitted in accordance with Torrent Pharma UK company expectations.
Key Duties and 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 in-house, 3rd party designers and contract sites for packaging artwork development and updates.
- Work with outsourced Pharmacovigilance team for new MA applications, submissions related to Summary of Product Characteristics (SmPC), Patient Information Leaflets (PILs) and renewals.
- 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 in-house,3rd party designers and contract sites for packaging artwork development and updates.
- Work with outsourced Pharmacovigilance team for new MA applications, submissions related to Summary of Product Characteristics (SmPC), Patient Information Leaflets (PILs) and renewals.
- 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:
- 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;
- Private Medical Insurance – Vitality Healthcare
- Life Insurance
- 25 days annual leave (in addition to public bank holidays)
- Enhanced Employer Pension contribution
- Hybrid Working - 2 days per week attendance to our office near Gatwick
- Onsite parking
How we use your data
Please refer to our privacy notice on our website www.torrentpharma.co.uk for more information.
