Job Description
Director, Regulatory Affairs Strategy
About the Rol
eWe are seeking a Director of Regulatory Affairs Strategy to lead the development and execution of global regulatory strategies across our clinical pipeline. This individual will serve as the primary regulatory strategist for one or more development programs, partnering closely with cross functional teams to drive programs from IND through approval. The role offers significant visibility with senior leadership and the opportunity to shape regulatory direction for novel therapeutics
.
Key Responsibiliti
- esDevelop and own global regulatory strategies for assigned programs, including US, EU, and key international marke
- tsServe as the regulatory lead on cross functional program teams, providing strategic guidance on study design, endpoints, and development pathwa
- ysLead preparation and execution of health authority interactions, including pre IND, End of Phase 2, Type B/C meetings, and scientific advice procedur
- esDirect the planning, authoring strategy, and submission of INDs, CTAs, BLAs, NDAs, and MAAs in collaboration with regulatory operations and external partne
- rsEvaluate and advise on expedited pathways such as Breakthrough Therapy, Fast Track, RMAT, PRIME, and Orphan Drug designatio
- nsMonitor the evolving regulatory landscape, competitor precedents, and guidance documents, and translate findings into actionable program strate
- gyIdentify regulatory risks early and develop mitigation plans, communicating clearly to program teams and executive leadersh
- ipManage and mentor regulatory staff and oversee consultants and CRO regulatory partners as need
- edContribute to due diligence assessments for business development and licensing opportuniti
es
Qualificati
- onsAdvanced degree in life sciences strongly preferred (PharmD, PhD, MS); RAC certification a p
- lus12+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry, with at least 3 years in a strategic or leadership capac
- ityDemonstrated success leading health authority interactions with FDA; EMA and other international agency experience prefer
- redDirect experience authoring and filing INDs and at least one major marketing application (BLA, NDA, or M
- AA)Deep knowledge of FDA and ICH regulations and guidance across the development lifecy
- cleTherapeutic area experience aligned with the company pipeline; biologics or novel modality experience a p
- lusStrong executive presence with the ability to influence cross functional teams and communicate complex regulatory issues sim
- plyComfortable operating in a fast paced, lean environment where strategy and execution go hand in h
and