Regulatory Affairs Officer

7 days ago

Crawley, United Kingdom Torrent Pharma UK Ltd Full time

**Company description**

TP-UK is a rapidly growing pharmaceutical company with an increasingly strong market presence within the UK market, operating within retail pharmacy, wholesale and hospital sectors. TP-UK stands on the principles of providing high quality prescriptive medicines at an affordable price.

Our focus is to expand an ever-increasing product portfolio through group development of key pharmaceutical molecules and key partner arrangements, across a range of therapies with particular focus on the treatment areas affecting the cardiovascular and central nervous system.

The Company, internationally, is ranked amongst the leaders in the therapeutic segments of cardiovascular (CV) and central nervous system (CNS) and has achieved significant presence in gastro-intestinal, diabetology, anti-infective, pain management, gynecology and pediatric segments. Recently it has been expanding it's presence in the therapeutic segments of oncology and rheumatology.

**Job 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 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
- Enhanced Employer Pension contribution of 5%
- Hybrid working - Choice of 2 days per week to attend our office near Gatwick
- Onsite parking

How we use your data

**Salary**: £28,000.00-£38,000.00 per year

**Benefits**:

- Company pension
- On-site parking
- Private medical insurance

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Crawley, RH10 9BG: reliably commute or plan to relocate before starting work (required)

**Experience**:

- Regulatory Affairs: 2 years (required)

Work authorisation:

- United Kingdom (required)

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