Executive Director leading digital regulatory submissions and pharmacovigilance transformations. Driving innovation and product strategy in a research-intensive biopharmaceutical company.
Responsibilities
Develop and promote a multiyear product strategy for Digital Regulatory & Safety, aligning with IT and Research and Development (R&D) priorities.
Act as a senior technology business partner to various stakeholders.
Define and drive adoption of target-state architecture and reusable capability layers across Regulatory and Pharmacovigilance.
Lead the responsible adoption of generative AI technologies for regulatory authoring and translations across R&D.
Develop and support the practice of product management, building the mindset and practice of end-to-end accountability of product lifecycle.
Build and scale a high-performing product organization, manage a group of 40-60 technology professionals.
Requirements
Bachelor’s degree in IT, computer science, life sciences, or related discipline; advanced degree preferred.
12+ years of progressive technology/product leadership in pharmaceutical, biotech, or regulated life sciences.
5+ years of experience in technology enablement for regulatory or safety, with management responsibilities.
Proven track record in setting and delivering product strategy in regulatory affairs and pharmacovigilance domains.
Outstanding interpersonal and communication skills.
Proven experience in team building, mentoring, and leadership.
Experience managing strategic vendor relationships and third-party platform implementations.
Preferred: Experience with Veeva (Vault Regulatory, Vault Docs) or equivalent regulatory authoring/publishing platforms.
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
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