Global Regulatory Affairs Consultant
2 months ago
Apsida Life Science has partnered with a leading Pharmaceutical company looking for a Global Regulatory Affairs Consultant.
The Global Regulatory Affairs Consultant will lead global regulatory strategies for marketing authorization submissions across emerging markets. The role involves working with submissions managers and regional teams to ensure timely, high-quality submissions, while managing risks and maintaining regulatory compliance.
Duties:
- Develop Global Regulatory Strategies: Lead global strategies for simultaneous submissions, including innovative and accelerated pathways.
- Identify and mitigate risks to protect business interests and prevent delays.
- Submission Planning: Collaborate on detailed plans for individual country filings, including approvals and regulator meetings.
- Lead Global Filing Teams: Coordinate teams to update core documentation and generate country-specific data for submissions.
- Dossier Adaptation: Tailor core dossiers for country-specific requirements and finalise documents.
- Compliance & Systems: Manage regulatory submissions in systems like Veeva Vault, ensuring alignment with internal policies..
- Guide teams in preparing for pre-submission and review meetings with regulators.
- Innovate Regulatory Processes: Propose innovations to expedite regulatory approvals.
- Collaboration & Communication: Work closely with local teams and report key issues to senior management
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