Pharmaceutical Regulatory Specialist
7 days ago
The opportunity to make a meaningful impact in the pharmaceutical industry is here.
We are seeking an experienced Regulatory Affairs professional to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring the accuracy and compliance of product information for European procedures.
- Ensure pharmaceutical, medical, and regulatory accuracy of English product information for EU procedures.
- Provide internal expertise to address inquiries and resolve labeling issues.
- Ensure regulatory compliance for all maintained innovative, biosimilar, and generic EU procedures.
Key Responsibilities:
LabelingCreate and update compliant English product information for EU procedures.
Provide instructions and guidance to local RA teams.
Evaluate and approve change requests.
Coordinate submissions with EU regulatory units.
Collaborate on patent-related issues with Global IP Group.
MonitoringMonitor safety updates from EU authority websites.
Track reference product updates and legal guidance changes affecting product information.
PharmacovigilanceImplement PV triggered and non-PV triggered safety updates.
Collaborate on safety-related actions with Pharmacovigilance and QA teams.
Participate in Product Safety Group (PSG) meetings.
Scientific Work & Authority CommunicationRespond to authority deficiency letters in collaboration with other departments.
Coordinate creation and approval of packaging mockups.
Address authority queries and ensure compliance with EU regulations.
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