Senior Director of Risk and Compliance
S&P GlobalLead client security negotiations and regulatory compliance risk for S&P Global Market Intelligence. Advise Sales, Legal, and technical teams on enterprise security commitments.
Deschide
Torrent Pharma UK Ltd este filiala din Regatul Unit a Torrent Pharmaceuticals Limited, un producător farmaceutic global. Compania produce și distribuie medicamente generice eliberate pe bază de prescripție și deține peste 300 de autorizații pentru produse în Regatul Unit, în mai multe arii terapeutice. Activitatea sa include extinderea portofoliului prin dezvoltarea de molecule farmaceutice, cu accent pe disponibilitatea medicamentelor la prețuri accesibile.
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.
Descriere
- 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.
Cerințe
- 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.
Beneficii
- Collaborative, supportive approach to teamwork.
- Participative decision-making.
- Opportunity to contribute to a positive team environment.
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