Senior Vice President, Regulatory Affairs

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $390k - $415k / year

⏰ Full Time

🟠 Senior

👔 Vice President

👻 Ghost score 0%

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Notified

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

📣 Marketing

☁️ SaaS

🤝 B2B

Marketing • SaaS • B2B

Notified is a B2B SaaS company that provides media monitoring and communications software for PR and marketing teams. It helps organizations track media coverage, social mentions, and influencer activity; measure campaign performance and audience reach; and manage communications and stakeholder engagement across earned, owned, and social channels. Notified’s platform is used by enterprises and agencies to centralize insights, reporting, and workflows for public relations and corporate communications.

📋 Description

• Drive the global regulatory strategy, partnering with Clinical Development to shape development plans, trial designs, and endpoints • Provide executive oversight and strategic direction for health authority interactions, including product labeling and safety changes • Oversee global post-approval submissions, including supplemental NDAs, line extensions, manufacturing variations, and renewals • Build the ex-US regulatory approach across priority markets, applying reliance and joint-review pathways where appropriate • Lead commercialization activities and cross-functional alignment across Commercial, Medical Affairs, Quality, and Supply Chain • Ensure timely submission of periodic safety update reports and annual reports, and compliance with global post-marketing commitments • Serve as the senior regulatory authority and maintain productive relationships with regulatory agencies and external advisors • Partner with the Executive team and cross-functional leaders across Clinical Development, Commercial, Quality, CMC, and Legal • Build, lead, and develop a high-performing global Regulatory Affairs function • Build and evolve Regulatory Affairs organization, capabilities, processes, and external partnerships • Provide strategic and operational guidance to project teams on regulatory submissions and compliance activities

🎯 Requirements

• 15+ years of progressively responsible Regulatory Affairs experience in the biopharmaceutical industry, including significant experience leading regulatory strategy and teams • Successful experience with NDA submissions and major health authority interactions • Experience with small molecules and cardiometabolic diseases is preferred • Proven track record leading regulatory strategy for lifecycle expansion, working closely with Clinical Development on programs, expedited pathways, and global launch readiness • Experience in a commercial-stage biotechnology or pharmaceutical environment • Strong knowledge of regulatory requirements for product labeling, promotional review, and post-marketing commitments • Mastery of ICH guidelines, FDA and EMA post-marketing regulations, labeling negotiations, and CMC lifecycle requirements • Strong cross-functional leadership experience with Clinical Development, CMC, Quality, Commercial, and Legal teams • Proven track record of building and mentoring high-performing regulatory teams and influencing executive strategy • Advanced degree preferred, including PharmD, PhD, MD, or equivalent in a scientific or healthcare discipline • Up to 20% travel, frequently outside the local area and overnight

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Time off • 401K • Participation in Mineralys incentive plans contingent on achievement of personal and company performance • Fully remote work arrangement

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