Vice President, Regulatory Affairs

🕒 July 7

⚔️ Virginia – Remote

⚔️ Virginia – Remote

💵 $200k - $275k / year

⏰ Full Time

🔴 Lead

👔 Vice President

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Contraline

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

⚕️ Healthcare Insurance

🌍 Social Impact

Healthcare • Healthcare Insurance • Social Impact

Contraline is a company deeply involved in providing comprehensive mental health and substance misuse services. With a focus on both adults and children, Contraline offers a wide array of therapeutic services from individual, couples, to group therapy sessions. They also emphasize community support and assertive community treatment while addressing psychiatric evaluations and medication management needs. Their services extend uniquely to the deaf and hard of hearing community, homeless outreach programs, and specialized treatment for individuals experiencing early psychosis. Contraline integrates these efforts with physical health care services to ensure holistic support. Its mission includes striking down stigma, sharing transformative stories, and encouraging community engagement in mental health conversations.

📋 Description

• Develop and execute innovative regulatory strategies that maximize development efficiency and increase probability of approval. • Serve as the primary regulatory contact with FDA for Contraline and other health authorities worldwide. • Lead all regulatory aspects of product development from preclinical stages through commercialization. • Provide strategic input when required into corporate planning, fundraising activities, business development transactions, and investor communications. • Participate in nonpromotional and promotional review as the Regulatory Affairs representative. • Build and scale the regulatory affairs function as the organization grows. • Lead preparation for regulatory agency meetings including Pre-IND, Type B, End-of-Phase 2, and Pre-NDA/BLA interactions. • Oversee preparation and submission of INDs, NDAs, BLAs, amendments, and global regulatory applications. • Provide regulatory leadership for drug-drug combination products and drug-device combination products. • Collaborate closely with Clinical Development, CMC, Quality, Nonclinical, Medical Affairs, and external partners. • Evaluate emerging regulatory risks and opportunities and provide proactive mitigation strategies. • Support diligence activities related to partnerships, licensing opportunities, and acquisitions.

🎯 Requirements

• Advanced scientific degree (PhD, PharmD, MD, MS, or equivalent) in a relevant discipline and/or Regulatory Affairs Certification (RAC) • Minimum 15 years of regulatory affairs experience in pharmaceutical and/or biotechnology companies • Significant experience leading FDA interactions and major regulatory submissions including experience with 505(b)(2) submissions • Demonstrated success obtaining IND clearances and advancing development programs through key regulatory milestones • Experience developing regulatory strategies for innovative therapeutic products. • Strong understanding of clinical development, CMC, nonclinical development, and commercialization requirements. • Proven ability to operate effectively in entrepreneurial, resource-constrained environments.

🏖️ Benefits

• Applicants must be authorized to work in the United States • Dedicated to building a diverse, inclusive and authentic workplace