Compliance

• Develop overall regulatory strategy for assigned programs, working closely with the nonclinical and clinical teams, in conjunction with the Regulatory CMC and Device leads
• Provide regulatory leadership as the Global Regulatory Lead to program teams and subteams as the go to point of contact for regulatory strategy on assigned program(s)
• Lead the Regulatory Strategy Subteam(s) in the development of global regulatory plans to support assigned program(s)
• Collaboratively identify regulatory risks to product development and design risk mitigation strategies as aligned with cross-functional SMEs
• Provide regulatory support and contribute to the development and implementation of regulatory strategies to support the approval and commercialization of assigned products in compliance with applicable Health Authority requirements, including the identification of gaps or risks and opportunities to expedite development through innovative pathways
• Collaborate cross-functionally with internal teams and subject matter experts to provide regulatory guidance and support throughout the product lifecycle and to prepare regulatory submissions (eg, meeting requests, briefing documents, IND/CTA filings, marketing applications, designation requests, etc…)
• Lead content development, organization, and coordination of cross functional regulatory submissions (e.g., INDs, CTAs, BLA, etc…)
• Author, coordinate, review, and execute submissions and responses to regulatory authorities related to INDs, CTAs, amendments, Information Requests, within appropriate timelines and in accordance with regulations and guidelines.
• Maintain detailed knowledge of the evolving global regulatory landscape relevant for advanced therapies including accelerated review programs. Assess the impact of new regulations/guidance on internal programs and communicate relevant changes to internal stakeholders
• Contribute to regulatory department initiatives to develop procedures and working practices

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