FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Regulatory Affairs – Pharmacovigilance Officer
Torrent Pharma UK Ltd. Support eCTD submissions for Torrent Pharma UK and the Group .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs and Pharmacovigilance within the UK pharmaceutical industry, with a strong focus on eCTD submissions, compliance with MHRA requirements, and maintaining accurate regulatory documentation.
Highest-signal resume keywords
Regulatory Affairs ExperiencePharmacovigilance CoordinationECTD Submissions KnowledgeMHRA Compliance UnderstandingRegulatory Documentation Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
ECTD SubmissionsRegulatory ComplianceProduct Lifecycle ActivitiesRegulatory Records MaintenanceArtwork CoordinationSafety DocumentationSmPC ChecksCTD Dossier CompilationRegulatory Procedures PreparationImpact Assessments
Soft Skills
Excellent OrganisationAttention to DetailProactive Problem-SolvingStrong CommunicationInterpersonal SkillsCollaborative Teamwork
Tools & Technologies
Regulatory DatabasesPV TrackerLabelling Systems
Industry Keywords
Pharmaceutical IndustryMarketing AuthorisationVariationsRenewalsMHRA RequirementsPSURsRMPs
About the role
Key responsibilities & impact- 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 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
- Provide source information for PSURs, 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/PIL updates
- Maintain accurate regulatory files, databases, submission histories and marketing authorisation records
- Contribute to the preparation and review of regulatory procedures and cross-functional processes
- Identify regulatory compliance gaps, support impact assessments and corrective actions, and collaborate with internal teams and contract manufacturing partners
Requirements
What you’ll need- 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
- Working knowledge of eCTD submissions and product lifecycle activities, including variations, renewals and artwork coordination
- Experience maintaining regulatory records, databases and trackers with a high degree of accuracy
- Excellent organisation and attention to detail
- Ability to prioritise competing deadlines and take a proactive approach to problem-solving
- Strong communication and interpersonal skills
- Collaborative, supportive approach to teamwork
Benefits
Comp & perks- Collaborative, supportive approach to teamwork
- Participative decision making
- Contribution to a positive team environment