Regulatory Affairs Specialist
5 days ago
F. Hoffmann-La Roche Gruppe fosters a culture of diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs.
The RoleJob Summary
- This position will carry out regulatory affairs responsibilities and activities for assigned products and tasks.
- Responsibility as Company Pharmacist may be required.
- Collaboration with both internal and external cross-functional team members, as well as with external stakeholders, is expected.
- All employees are expected to practice high standards of compliance with both external and internal policies and regulations.
Key Responsibilities and Accountabilities
Strategy/Planning:
- Gather, analyze and communicate internal and external regulatory intelligence.
- Provide regulatory expertise and input into cross-functional business strategies.
- Develop innovative registration plans and submissions strategies for Affiliate products.
- Represent Affiliate Regulatory in cross-functional teams if delegated by Regulatory Affairs Lead.
- Provide updates and status reports on regulatory/registration activities.
Filings:
- Prepare and manage regulatory registration filings across product life cycles.
- Maintain/updating of registered products for any changes/updates post-approval commitments.
- Monitor and communicate all regulatory filings status and respond to stakeholders.
- Ensure timely regulatory filings submissions and approvals.
Information and Documentation Management:
- Manage Affiliate regulatory activities on relevant systems.
- Manage product information updates with respect to Roche and local regulatory requirements.
Regulatory Compliance:
- Develop and maintain current knowledge of international and local regulations.
- Ensure regulatory inspection-readiness for the Affiliate.
- Ensure regulatory compliance for product released to market.
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