Vice President, Regulatory Strategy at Lumanity | chakrie

Requirements

Additional Requirements

Minimum 20+ years progressive regulatory experience with demonstrated success in both consulting environments and in-house biopharma regulatory leadership roles
Direct experience leading regulatory strategies for development programs throughout all stages and across different therapeutic areas and product types
Demonstrated success managing regulatory practices or teams
Proven ability to serve as trusted advisor to pharmaceutical/biotech VP-level and C-suite executives
Deep expertise across pre-IND through post-market regulatory activities, including designations, accelerated approval pathways, and complex regulatory strategies
Extensive experience leading Pre-IND meetings, Type C meetings, EOP2 discussions, and other critical regulatory interactions
International regulatory experience across major markets (EMA, Health Canada, PMDA) with understanding of global regulatory harmonization
Deep regulatory expertise in 2+ major therapeutic areas (oncology, CNS, rare disease, immunology, etc.)
Experience across multiple product types including small molecules, biologics, cell/gene therapies, and combination products
PhD, MPH, or MS in life sciences, regulatory affairs, or related field
MBA, RAC certification, or equivalent business/regulatory qualifications
Proven track record achieving annual revenue targets with demonstrated budget management experience
Success in opening new markets or service lines within regulatory consulting
Published regulatory thought leadership, speaking engagements, and recognition as regulatory industry authority

Responsibilities

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Skills & expertise

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

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Salary & benefits

A clear overview of what is expected, written by the people who posted it, with every detail you need to decide.

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

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Vice President, Regulatory Strategy

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Additional Requirements

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Summary

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Additional Requirements

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