Regulatory Affairs & Pharmacovigilance Officer

Department:
Regulatory Affairs

Reporting to: RA & QA Manager

Location:

Crawley, UK

Working arrangement:
Hybrid

We are looking for a motivated, detail-oriented Regulatory Affairs & Pharmacovigilance Officer to support the regulatory compliance and ongoing lifecycle management of Torrent Pharma UK’s pharmaceutical portfolio. You will coordinate submissions and product information updates, support pharmacovigilance obligations, and work closely with colleagues, external partners and regulatory authorities to deliver accurate, timely regulatory activities.

• Support eCTD submissions for Torrent Pharma UK and the Group; prepare and submit marketing authorisation variations and renewals to agreed deadlines.
• Carry out product information compliance activities in line with MHRA requirements, including monthly Summary of Product Characteristics (SmPC) checks.
• Compile administrative documentation for CTD dossiers and liaise with regulatory authorities to support submissions and approvals.
• Review, approve and release packaging and labelling documentation; coordinate artwork development and updates with designers and manufacturing sites, and maintain labelling systems.

• Coordinate pharmacovigilance activities and maintain the PV tracker accurately and up to date.
• Provide source information for Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and renewals; coordinate regulatory submissions and responses to requests for information.
• Work with the outsourced PV provider on new marketing authorisation applications, safety documentation and SmPC/Patient Information Leaflet (PIL) updates.

• Maintain accurate regulatory files, databases, submission histories and marketing authorisation records, with clear tracking of document changes.
• Contribute to the preparation and review of regulatory procedures and cross-functional processes, following company policies and guidelines.
• Identify regulatory compliance gaps, support impact assessments and corrective actions, and collaborate with internal teams and contract manufacturing partners.

• A degree in Pharmacy, Life Sciences or a related scientific discipline.
• Experience in Regulatory Affairs and/or Pharmacovigilance within the UK pharmaceutical industry.
• Working knowledge of MHRA requirements, eCTD submissions and product lifecycle activities, including variations, renewals and artwork coordination.
• Confidence maintaining regulatory records, databases and trackers with a high degree of accuracy.

• Excellent organisation and attention to detail, with a methodical and accurate approach.
• The ability to prioritise competing deadlines and take a proactive approach to problem-solving.
• Strong communication and interpersonal skills, and a collaborative, supportive approach to teamwork.

Our work is guided by integrity, passion for excellence, participative decision making, concern for society and the environment, fairness with care, and transparency. We value people who put these principles into practice and contribute positively to our team.