10 days ago
Hamlyn Williams has partnered with a rapidly expanding global pharmaceutical company based in London. This global pharmaceutical firm is currently in a major phase of growth due to its innovative and expansive pipeline and are looking for a Regulatory Affairs Associate on a permanent basis.
The role will involve but not be limited to:
- Tracking of required Innovator labeling updates to completion as per required timelines.
- Monitoring of the Global RA calendar/tracker tool to drive compliance for safety and/or labeling changes resulting from submissions.
- Maintenance of documents, including initiation, review, and/or approval of document change requests for new documents and revisions.
- Prepare and report out all Regulatory PV-related KPI metrics in the appropriate format in line with European regulator expectations
- Monitor all PV-related compliance activities including 180 day implementation of labeling changes, generate labeling change controls associated with PRAC, CCDS, PSUR and safety-related updates
- Draft and document all appropriate deviations related to implementation of safety labeling updates
- Participation in Global Safety Labeling & CCDS cross functional meetings. Scheduling and preparing meeting minutes/summaries as required.
As a Regulatory Affairs Associate, you will need:
- Good Manufacturing Practice (GMP) and Pharmacovigilance (PV) knowledge required.
- Strong knowledge of EU regulations and requirements for labeling.
- Knowledge of PV safety and reporting requirements for EU region.
- Intermediate skills in Microsoft Office, particularly Excel and Word.
I am a market expert in the Regulatory Affairs area working with a large variety of clients across the pharmaceutical and biotechnology industries. If this role is of interest to you, or if you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Sonny Bains at +44 020 8164 5340 or at firstname.lastname@example.org.