Regulatory and Compliance Advisory Board Member - New York - Wave Bye Inc

    Wave Bye Inc
    Wave Bye Inc New York

    3 days ago

    Description


    About Wave Bye Wave Bye helps women take control of their menstrual cycles through OB/GYN-developed, non-hormonal treatments designed to reduce pain, regulate cycles, and improve the period experience.

    Founded by Dr.

    Margo Harrison, MD, MPH, an OB/GYN trained at Yale, Hopkins, and Columbia, Wave Bye exists to give women back the seven years of life lost managing menstrual symptoms.

    Alongside our complementary consumer-health products (Bye Cramps, Bye Bad Cramps, Bye Irregularity), Wave Bye is building the first integrated menstrual-health platform, uniting: FDA-regulated pharmaceutical innovation Digital cycle tracking and personalization Evidence-based clinical care pathways Our products have earned 4.9 stars, with strong endorsements from clinicians and women's-health professionals.

    Customers consistently report shorter periods, reduced bleeding, less pain, and a meaningful return to normal daily functioning.

    Wave Bye is now expanding its leadership network as we transition into large-scale clinical development, regulatory submission, and enterprise adoption.

    Job Summary Wave Bye is seeking an experienced Regulatory & Compliance Advisor to join its Advisory Board.

    Advisors will help shape Wave Bye's regulatory strategy, compliance frameworks, FDA 505(b)(2) pathway planning, evidence alignment, and readiness for large-scale clinical advancement and enterprise deployment.

    This role is ideal for leaders who understand how regulated healthcare products navigate complex compliance ecosystems, who have experience with FDA pathways such as 505(b)(2), and who can advise on positioning evidence for regulatory, payer, and employer audiences.

    Key Responsibilities Regulatory Strategy & Pathway Planning Advise on regulatory strategy, including FDA 505(b)(2) pathway planning and global regulatory considerations.

    Provide insight into optimal pre
    • IND/IND and NDA planning, submission timing, and documentation readiness.
    Assist in interpreting regulatory guidance and trends impacting menstrual-health therapeutics. Compliance & Quality Systems Advise on quality systems, design controls, documentation practices, and regulatory readiness. Support development and evaluation of regulatory policy, SOPs, and compliance checklists aligned with FDA and international expectations.

    Clinical & Evidence Positioning Provide strategic guidance on how clinical and real-world evidence should be framed for regulatory bodies, payers, and enterprise partners.

    Support discussions around labeling strategy, safety data reporting, and product claims consistent with regulatory standards. Partnership & Regulatory Engagement Support introductions to regulatory consultants, regulatory affairs networks, and subject-matter experts. Advise on engaging with regulatory agencies, advocacy groups, and professional societies to support strategy alignment. Governance & Risk Mitigation Help shape Wave Bye's risk-management framework, regulatory governance, and compliance roadmap as the company scales. Provide high-level compliance oversight on regulatory submissions, audits, and review planning.

    Ideal Candidates We're seeking senior leaders with backgrounds such as:

    Regulatory affairs executives (Regulatory Strategy, VP/Director, Head of Regulatory Affairs) Compliance leaders with experience in FDA-regulated product development Former or current regulatory reviewers or consultants with experience in 505(b)(2) submissions Operators from pharma, biotech, or medical device companies with regulatory oversight experience Healthcare executives with experience launching clinically validated or FDA-regulated products Healthcare investors with regulatory strategy expertise Preferred Experience 10+ years in regulatory affairs, compliance, or product registration strategy Experience designing and executing FDA 505(b)(2) regulatory pathways Familiarity with FDA submissions (IND/NDA/505(b)(2)), labeling considerations, and post-market compliance Understanding of payer or employer evidence expectations and regulatory impact on adoption Track record creating regulatory frameworks for clinical or consumer healthcare products Why Join Wave Bye Advance Women's Health at Scale Play a pivotal role in shaping how a new class of FDA-regulated menstrual-health therapeutics reaches the market.

    Collaborate with Leaders in Innovation Work directly with Dr. Margo Harrison and a multi-disciplinary team of clinicians, scientists, and regulatory experts.

    Contribute to Regulatory Success Guide a company preparing for large-scale clinical trials and FDA interactions that will drive approval and adoption.

    Join at a Critical Inflection Point Wave Bye is entering a phase of scientific expansion, evidence generation, and enterprise adoption where regulatory strategy is central to success.


    Compensation & Investment Opportunity Advisory Participation:
    Future equity or recognition for your strategic contribution

    Investment Opportunity:

    Option to participate in Wave Bye's upcoming SAFE round Impact: Shape regulatory strategy for FDA-aligned innovation in women's health Equal Opportunity Commitment Wave Bye is committed to building a diverse, inclusive, and high-impact Scientific Advisory Board that represents leaders across regulatory affairs, healthcare, pharma, and digital health.

    We welcome executives who share our commitment to advancing women's health outcomes through innovation, access, and scientific rigor.

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