Regulatory Affairs Assistant
3 weeks ago
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 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.
- 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.
- 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
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