Manager, Regulatory Affairs coordinating global regulatory submissions for therapeutic development. Collaborating cross - functionally to meet regulatory agency requirements and ensure compliance.
About the role
- 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)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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