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Bachelor’s degree in life sciences or equivalent discipline is required; Advanced degree (MS, PhD, PharmD) preferred. US RAC and PMP certification a plus.
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Minimum of 10-years’ experience working in a regulatory CMC function with direct responsibility for leading regulatory strategy, writing key documents (e.g. FDA briefing books, IMPD, IND, BLA, NDA), and directly interfacing with health authorities (i.e. FDA, EMA).
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Critical ability to work closely with in-house Subject Matter Experts (SMEs) and Contract Manufacturing Organizations (CMOs) to acquire critical information in support of preparing the various segments of Module 3 and responses to Health Authority questions and issues
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Major capability to set, monitor and meet CMC Module 3 and other Regulatory CMC timelines and deadlines
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Experience in working with CMC Regulatory formats and templates for eCTD compilation of information and data displays
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Prior experience participating in and writing documents for the FDA and other Health Authorities required.
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Direct experience developing early and late-phase programs for combination products, biologics, and/or innovative technologies.
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Direct experience participating in cross-functional teams in a matrix environment.
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Experience working in both large pharmaceutical and small biotechnology organizations.
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Experience providing strategic regulatory CMC guidance to drug development, registration, and post-market support teams.
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Broad familiarization and current, working knowledge of GxP (i.e., GMP, GDP, GCP).
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Understanding and working experience with biological products, combination products, and innovative products in early and late-phase clinical development
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Strong verbal communication skills with the ability to articulate CMC/regulatory concepts across line functions and to external audiences is required.
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Ability to write regulatory high-quality documents (e.g., Briefing documents, IND amendments, IMPD, and other regulatory documents, etc.) is required.
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Experience with external and internal stakeholders to support global scientific and business strategies.
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Demonstrated working knowledge and experience of US, EU, and international regulatory requirements pertinent to this role.
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Exercise critical thinking, solution-oriented problem solving, strategic thinking skills with ability to impact and influence in a matrix environment and across functions.
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Strong analytical and business communication skills.
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Knowledge of French language is a strong plus
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Veeva RIM experience is a must
