Regulatory Manager / Senior Regulatory Manager

職位要求

• Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required
• Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
• Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information
• 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level
• Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialised knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.
• Candidates must have regulatory affairs experience working for a CRO or within the Pharmaceutical Industry, and have experience leading Clinical Submissions
• Candidates must be legally authorized to work in the country of employment without employer sponsorship.

原文資格條件

以下摘錄自招聘來源，適用條件請以原文為準。

• Candidates must be legally authorized to work in the country of employment without employer sponsorship.