Regulatory Affairs & Pharmacovigilance Officer

Torrent Pharma UK Ltd; Crawley Hill; Hybrid; GBP 42,000 - 62,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Torrent Pharma UK Ltd in Crawley, UK is seeking a Regulatory Affairs & Pharmacovigilance Officer to support regulatory compliance and lifecycle management across the portfolio. The role involves coordinating submissions, PV obligations, and cross-functional collaboration to deliver accurate regulatory activities.

The candidate will coordinate eCTD submissions, ensure SmPC alignment, and maintain PV tracking while liaising with authorities and external partners.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory affairs

Pharmacovigilance

eCTD submissions

MHRA knowledge

Documentation control

Attention to detail

Team collaboration

Education

Degree in Pharmacy / Life Sciences

Job description

Department: Regulatory Affairs

Reporting to: RA & QA Manager

Location: Crawley, UK

Working arrangement: Hybrid

The opportunity

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.

What you’ll be doing

Regulatory affairs & product lifecycle

• 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.

Pharmacovigilance support

• 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.

Data integrity, quality & collaboration

• 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.

What you’ll bring

Knowledge & experience

• 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.

Personal strengths

• 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.

Working at Torrent Pharma UK

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.

Interested in joining us?