Serve as CMC regulatory expert, developing global submission strategies and assessing regulatory risks for development and commercial programs.
Lead preparation and review of CMC submission content including CTD Module 2 and Module 3 sections, and support regulatory filings from IND to MAA.
Guide CMC lifecycle management, regulatory authority interactions, and monitor emerging regulations to inform client strategies.
Opus Regulatory is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo to biotech and pharmaceutical clients. Their team is made up of biopharmaceutical leaders and innovators focused on delivering the highest level of regulatory consulting service.
Lead regulatory strategy for oncology drug development programs, ensuring alignment with US and global health authorities.
Plan and manage Clinical Trial Applications, Market Applications, and amendments with high-quality submissions.
Collaborate cross-functionally to integrate evolving regulations and drive process improvements.
Iovance Biotherapeutics is a global leader in developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, with an FDA-approved treatment for advanced melanoma. The company operates as an end-to-end cell therapy organization with U.S.-based manufacturing, serving thousands of cancer patients worldwide.
Lead global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities.
Build, lead, and develop a high-performing CMC Regulatory team as the company scales.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.
Lead Loyal's overall regulatory strategy across CMC and clinical activities, from early development through post-approval lifecycle management.
Act as the primary liaison with global regulatory agencies and own approval submission strategy and execution.
Build and scale a high-performing regulatory organization, establishing governance frameworks and eCTD publishing capabilities.
Loyal is a clinical stage veterinary medicine company developing longevity drugs for dogs. It is a well-funded startup led by a first gen female CEO, with a culture focused on innovation, transparency, and empathy for all life.
Provide regulatory strategy and guidance across the clinical development lifecycle, including submissions to Regulatory Authorities and Ethics Committees.
Coordinate and prepare regulatory documents such as CTA/IND, annual reports, amendments, orphan designations, and marketing applications.
Represent Global Regulatory Affairs at project team meetings, lead submission projects, and mentor Regulatory Affairs Specialists.
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences, focusing on Oncology and Rare Disease. They are a growing global team that values employee contributions and fosters an environment where ideas are valued and nurtured.
Lead U.S. and global regulatory strategies for oncology biologic development programs.
Prepare and manage Clinical Trial Applications, Marketing Applications, and regulatory amendments.
Collaborate with cross-functional teams to align regulatory plans and manage program risks.
A partner company is seeking a strategic regulatory affairs leader to support innovative oncology biologic and cell/gene therapy development programs. The company offers a fully remote environment with global regulatory exposure and cross-functional collaboration.
Develops and drives regulatory strategy for FDA Pharma and IVDR initiatives.
Represents the regulatory function on cross-functional teams and interacts with regulatory authorities.
Coordinates regulatory submissions and ensures compliance with global requirements.
Natera is a clinical genetic testing company specializing in non-invasive cell-free DNA and liquid biopsy testing. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.
Contribute to regulatory strategies and coordinate interactions with health authorities.
Manage preparation and submission of INDs/CTAs, BLAs, annual reports, and safety reports.
Collaborate with cross-functional teams to ensure GXP compliance and support regulatory inspections.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. It leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells, with a culture driven by scientists and industry veterans.
Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory submissions.
Provide hands-on CMC regulatory expertise across global filings, health authority interactions, and post-approval activities.
Collaborate with cross-functional teams to align regulatory strategy with scientific and compliance requirements.
The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.
Set the strategic direction and long-term roadmap for Extend's regulatory compliance program, spanning licensing, service contracts, and insurance.
Serve as the executive-level owner for regulatory and licensing matters, representing compliance in front of regulators and auditors.
Partner with cross-functional teams to embed compliance requirements into merchant onboarding, customer experience, and product workflows.
Extend provides AI-driven solutions for retailers to enhance post-purchase customer satisfaction and drive revenue growth. The company works with more than 1,000 merchant partners, is backed by prominent technology investors, and is headquartered in downtown San Francisco.
Own and execute the elluminate business development territory strategy to achieve revenue targets and sales quota with new accounts.
Serve as a trusted advisor to senior client stakeholders and build long-term strategic relationships for account expansion and retention.
Collaborate cross-functionally with product, finance, and legal teams to align offerings with market needs and drive complex deals.
eClinical Solutions helps life sciences organizations accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud. It is a fast-growing company where employees make an impact on the future of healthcare.
Own integrated program strategy for TIL cell therapy assets across early-to-late-stage clinical development.
Chair cross-functional program teams, manage timelines, and translate strategy into execution.
Partner with senior leadership to advance programs from early studies to global regulatory submissions.
Iovance Biotherapeutics is a global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors. The company operates as an end-to-end cell therapy company with fully owned, centralized U.S.-based manufacturing and is committed to a diverse and inclusive work environment.
Serve as the Legal representative on the Promotional Review Committee and Medical Review Committee, reviewing HCP-facing, patient-facing, medical, and corporate materials for compliance with FDA regulations and industry codes.
Provide practical legal guidance across pre-launch and launch activities, including patient education, digital content, and patient support programs, balancing legal risk with business objectives.
Review non-promotional materials, evaluate claims for substantiation, and advise on compliantly navigating the regulatory landscape for digital, social, and medical affairs content.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease, obstructive sleep apnea, and other diseases driven by dysregulated aldosterone. Headquartered in Radnor, Pennsylvania, Mineralys is a fully remote company with a collaborative, fast-moving culture.
Develop and maintain integrated project plans for global regulatory submissions, ensuring adherence to scope, timelines, budgets, and quality standards.
Act as the primary regulatory timeline contact across Clinical, Nonclinical, CMC, Quality, and Commercial functions, fostering collaboration and alignment.
Identify and mitigate project risks, prepare teams for agency meetings, and lead responses to regulatory queries from global health authorities.
Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 agonists for narcolepsy and other sleep-wake disorders. As a wholly owned subsidiary of Eli Lilly and Company, it shares a culture of caring and impact with over 50,000 employees.
Execute regulatory oversight for advertising, promotion, medical communications, and labeling across the product lifecycle.
Provide proactive regulatory strategy and risk-based guidance to commercial and medical review committees.
Lead FDA OPDP/APLB interactions and cross-functional labeling negotiations with health authorities.
Kyverna Therapeutics is a biopharmaceutical company developing cell therapies for autoimmune diseases. It is a growth-stage biotech with a collaborative, solutions-oriented culture and a focus on regulatory excellence.
Conduct compliance reviews, mock SEC/FINRA examinations, and branch office assessments for investment advisers and broker-dealers.
Manage client engagements from planning and testing through reporting and remediation, translating complex regulatory requirements into risk-rated findings.
Mentor junior consultants, contribute to industry education, and guide clients in using compliance technology solutions.
This company provides compliance consulting services to financial services firms, helping investment advisers and broker-dealers strengthen regulatory frameworks and maintain audit readiness. It fosters a collaborative, technology-driven culture with opportunities for professional development, mentorship, and industry thought leadership.
Build trust with state healthcare regulatory boards and agencies to drive growth of the CE Broker solution.
Serve as the primary point of contact for assigned state partners, guiding operational efficiency and compliance.
Navigate multi-year government decision cycles with a consultative, relationship-first approach.
Propelus simplifies workforce compliance management across healthcare, providing technology and strategic partnerships that empower professionals, employers, and regulators. A trusted leader for over 20 years, the company serves millions with seamless compliance solutions and has been named a BuiltIn 2025 Best Places to Work.
Monitor global regulatory developments across 150+ countries and assess impact on pharmaceutical and MedTech industries.
Ensure accurate structured data entry in the regulatory intelligence platform, combining GxP knowledge with data operations.
Communicate regulatory updates and trends clearly to support smarter, faster decisions across the enterprise.
Redica Systems is the Intelligence Cloud for life sciences, transforming regulatory complexity into connected, proactive intelligence. Their platform helps leading pharmaceutical and MedTech companies stay inspection-ready, manage supplier risk, and comply with global regulations in a fast-paced, high-growth environment.
Develop and lead Higgsfield's policy approach across products and platform.
Advise leadership on complex policy questions and establish decision-making frameworks.
Partner with Product, Legal, and Communications on policy, regulatory, and safety matters.
Higgsfield AI is the fastest-scaling generative AI company, reaching $1B in annual revenue run rate and powering 390 Fortune 500 brands. With 30M+ users worldwide, they are a high-impact, fast-moving team building at the frontier of AI-powered video creation.
Provide clinical, scientific, and strategic expertise to drug development programs from lead compound identification to launch.
Lead execution of clinical development plans, including trial documents, regulatory interactions, and cross-functional alignment.
Establish and maintain relationships with external medical experts and represent Ipsen at investigator meetings and scientific conferences.
Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With teams in more than 40 countries, it champions human-centric leadership and fosters a culture of collaboration, excellence and impact.