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Torrent Pharma UK Ltd is the UK subsidiary of global pharmaceutical manufacturer Torrent Pharmaceuticals Limited. The company manufactures and distributes generic prescription medicines, with more than 300 UK product licences across a range of therapy areas. Its work includes expanding its portfolio through the development of pharmaceutical molecules, with a focus on making medicines available at affordable prices.
Regulatory Affairs and Pharmacovigilance Officer
Support Torrent Pharma UK’s regulatory submissions, product lifecycle management and pharmacovigilance. Coordinate MHRA compliance, product information, safety documentation and regulatory records.
Apraksts
- Support electronic CTD submissions for Torrent Pharma UK and the wider group.
- Prepare and file marketing authorisation variations and renewals by agreed deadlines.
- Ensure product information complies with MHRA requirements, including monthly SmPC checks.
- Assemble administrative CTD dossier documents and liaise with regulatory authorities to support submissions and approvals.
- Review, approve and release packaging and labelling documents.
- Coordinate artwork creation and updates with designers and manufacturing sites, and maintain labelling systems.
- Coordinate pharmacovigilance activities and keep the PV tracker up to date.
- Supply source information for PSURs, RMPs and renewals.
- Coordinate regulatory submissions and responses to information requests.
- Work with the outsourced pharmacovigilance provider on new marketing authorisation applications, safety documents and SmPC/PIL updates.
- Keep regulatory files, databases, submission histories and marketing authorisation records accurate.
- Help prepare and review regulatory procedures and cross-functional processes.
- Identify regulatory compliance gaps, support impact assessments and corrective actions, and work with internal teams and contract manufacturing partners.
Prasības
- Degree in pharmacy, life sciences or a related scientific field.
- Experience in regulatory affairs and/or pharmacovigilance in the UK pharmaceutical industry.
- Working knowledge of MHRA requirements.
- Working knowledge of eCTD submissions and product lifecycle activities, including variations, renewals and artwork coordination.
- Experience maintaining regulatory records, databases and trackers accurately.
- Strong organisation and attention to detail.
- Ability to manage competing deadlines and take a proactive approach to problem-solving.
- Strong communication and interpersonal skills.
- Collaborative and supportive approach to teamwork.
Priekšrocības
- Collaborative, supportive approach to teamwork.
- Participative decision-making.
- Opportunity to contribute to a positive team environment.
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