Regulatory Affairs Specialist managing regulatory processes for TidalSense medical devices in various global markets. Preparing submissions and ensuring compliance in fast - paced healthcare environment.
About the role
- Executive Director, Regulatory Affairs Liaison driving the strategy for ophthalmology drug development in General Medicine. Leading a team and ensuring regulatory objectives align with development and commercialization priorities.
Responsibilities
- oversee the development and implementation of global regulatory strategy for ophthalmology and retinal disease programs for multiple indications to minimize time to approval and optimize labeling
- provide oversight for direct reports and support them to function as the single global point of accountability for assigned projects
- oversee strategy, review and approve key regulatory deliverables, including submissions, external communications, background packages, local registration study protocols, and labeling
- represent the company at external initiatives, regulatory authority meetings, and internal committees as required
- provide strategic input into regulatory due diligence activities for licensing candidate review
Requirements
- B.S./M.S. in biological science or related discipline
- minimum of 12 years of relevant drug development experience, with a majority in regulatory affairs
- M.D./Ph.D. or PharmD. with a minimum of 9 years relevant drug development experience, with at least 7 years in regulatory
- demonstrated ability to deliver results independently while remaining aligned with leadership
- demonstrated scientific knowledge, effective communication, and thorough familiarity with worldwide regulatory agencies
- demonstrated success in securing original NDA/BLA approvals
- outstanding interpersonal, communication, and negotiation skills
- demonstrated leadership attributes, including experience building and leading high-performing teams or projects
Benefits
- medical
- dental
- vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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