Senior Regulatory Affairs Specialist
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The position involves managing regulatory activities and projects, developing strategies for new products, and handling submissions to regulatory authorities. This is a permanent role with an attractive benefits package.
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Key Responsibilities:
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1. Prepare high-quality CMC regulatory submissions for global agencies
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2. Contribute to regulatory strategies and manage submission information, tracking commitments and timelines
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3. Collaborate with stakeholders, provide consultation, and resolve regulatory issues
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4. Manage submissions for new registrations, post-approval changes, renewals, and line extensions
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5. Maintain global regulatory approvals and ensure timely responses to agency queries
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6. Lead regulatory affairs-related projects
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Essential Criteria:
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7. Bachelor's/Graduate degree in a relevant science discipline (Biology, Chemistry, Pharmacy)
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8. 3-5 years of Regulatory/CMC authoring experience in a Pharmaceutical company
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9. New market access filing and post approvals experience
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10. Experience liaising with Contract Manufacturers (CMOs)
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11. Excellent written, oral communication, and project management skills
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Core Competencies:
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12. Action-oriented, detail-focused, and results-driven
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13. Strong leadership, interpersonal, and presentation skills
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14. Ability to manage multiple projects and respond effectively to change
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