Global Regulatory Lead
il y a 3 semaines
Activities & responsibilities
Leadership on Regulatory strategy :
- Understand key features of the product(s) and relevant regulatory trends and competition across major markets (e.g.,guidelines, precedent) needed to assess the out comes of regulatory strategy(ies) throughout the product(s) lifecycle (e.g.,novel evidence generation, accelerated pathways, orphan, legalbasis,…)
- Ensure GRT has assessed current regulatory requirements (e.g., paediatric plans) and regulatory intelligence across major markets to support regulatory strategy needed to deliver the Target Product Profile
- Accountable for ensuring collaboration across internal stakeholders (e.g., Asset Team, GRT) to create and maintain the product’(s) global regulatory strategy aligned with the Regulatory Strategy Document
- Accountable for the overall regulatory strategy (e.g., ODD, registration, LCM) and major Health Authorities interactions (e.g., EMA, FDA, PMDA, CDE) in close collaboration with RRLs/LRA (HA primary point of contact) (exceptionally GRL may be HA contact for US and/or EU)
- Accountable for label development (i.e: Product information) and Company Core Data Sheet (CCDS), in collaboration with Labeling representative(s)
- Responsible, working with submission management and regional leads, for designing regulatory submission plan
- As Core Member of the team(s) representing Global Regulatory Team
- As owner, accountable for the Reference Dossier and oversees updates for line extensions, market expansion and/or variations
- Accountable for consistency and timely delivery of regulatory documentation throughout the life cycle (e.g., CTA/IND documents, core briefing book, slide set, Q&A, PIP/PSP, CTD Modules) to enable submission timelines
- Provides support to RRL/LRA in key markets to facilitate registration procedures
- Provides support to Market Access in key markets for the core value dossier
- Primary point of contact for all internal communications regarding project status on regulatory processes, strategy and delivery
- Interface with external partners (e.g., CDx providers, licensing partners)
- As needed, core member of In-Licensing and Due Diligence teams
- For CTA/IND, ensure that available regulatory documentation satisfies requirements necessary for study implementation (e.g., regulatory toxicology studies)
- Lead regulatory impact assessment in case of new findings (quality, efficacy or safety)
Profile
- Advanced degree in relevant scientific discipline or equivalent experience Master of Sciences M/S, Pharm D, PhD/MD preferred
- Knowledgeable in ICH, FDA and EMA guidelines and requirements
- Fluent in English. Good knowledge of French is an advantage
- Minimum of 5 years’ experience in managing regulatory process and registration aspects of the drug development process. Prior experience as experienced Global Regulatory Lead preferred
- Experience and stages of the product life cycle is a plus. Equivalent experience at a regulatory agency or in a relevant drug development role will also be considered
- Demonstrated ability to successfully prioritize multiple global tasks, projects and objectives within a defined portfolio
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