About this opportunity
Contraline, Inc. lists this Vice President, Regulatory Affairs opportunity in charlottesville, Virginia. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Contraline is a clinical-stage biotechnology company focused on innovation in male reproductive health. The company is advancing both hormonal and non-hormonal approaches to expand contraceptive options for men and couples globally.
Following its recently completed Series B financing, Contraline is entering a pivotal stage of growth as it advances toward late-stage clinical development, regulatory milestones, expanded manufacturing, and future product launch.
Serve as Contraline’s senior regulatory leader, responsible for developing and executing global regulatory strategies across a growing pipeline of innovative therapeutics and devices.
What you’ll do
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.
What you’ll need
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.
Exceptional leadership, communication, and stakeholder management skills
Contraline’s products are investigational and have not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.
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Worksite address
charlottesville, VA, 22904, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.