Lead the planning, authoring, and delivery of regulatory documents for global development programs, health authority interactions, and marketing applications.
Develop strategic document plans and author complex submissions such as INDs, CTAs, IBs, CSRs, and briefing packages while ensuring ICH/GCP compliance.
Coordinate cross-functional teams, manage external vendors, mentor junior writers, and drive process improvements to maintain submission readiness.
The company is a biopharmaceutical organization focused on developing innovative therapies for patients with significant unmet medical needs. It operates as a remote, cross-functional team with a culture emphasizing regulatory excellence, collaboration, and career development.
Lead safety evaluation and benefit-risk assessments for assigned products.
Support pharmacovigilance and risk management activities across clinical development and marketed products.
Contribute to regulatory submissions and health authority interactions.
Alphanumeric is a staffing and recruiting company that connects specialized professionals with global organizations. It is currently supporting one of the world's largest pharmaceutical companies in filling a contract medical director position.
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.
Review laboratory results, toxicology reports, and medical records related to substance exposure and impairment.
Provide expert testimony at depositions, trials, and legal proceedings via phone, video, or in person.
Collaborate with attorneys on case consultation and deliver CLE presentations to legal professionals.
Godoy Medical Forensics, Inc. is a rapidly growing legal consulting company that provides medical expert witness services to attorneys, primarily in criminal cases. Founded in 2009, we have evolved into a prominent consulting firm with a diverse team of experts, including physicians, toxicologists, forensic interviewers, and registered nurses.
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.
Establish and maintain a system to collect all suspected adverse reaction reports for company products.
Ensure requests from competent authorities for benefit-risk information are answered fully and promptly.
Oversee safety profiles, emerging safety concerns, and post-authorisation safety study commitments.
PrimeVigilance is a mid-size pharmacovigilance service provider and part of Ergomed PLC, supporting pharma and biotech partners with drug safety, regulatory affairs, and quality assurance. With staff across Europe, North America and Asia, it values well-being.
Lead analytical development and control strategy for sterile injectable/parenteral products from development through commercialization.
Define analytical CMC strategies and regulatory submissions, including NDA Module 3 content and specifications.
Oversee stability programs, method lifecycle management, and external CDMO and contract laboratory execution.
Kailera is a biopharmaceutical company advancing novel therapies for obesity and related conditions. The company is an inclusive, team-oriented workplace with an entrepreneurial spirit focused on collaboration, integrity, and excellence.
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.
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.
Design and execute stability studies across the gummy portfolio, tracking timepoints and sharing data with stakeholders.
Validate analytical methods, identify detection limits, and negotiate with external testing labs.
Own the complete documentation suite for every SKU, ensuring audit-ready specs and paper trails.
This high-growth product organization develops a diverse gummy supplement portfolio. They operate as a fully remote, high-trust team with biannual in-person off-sites.
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.
Collaborate with cross-functional teams to ensure accurate, timely, and compliant product information.
The hiring company is a pharmaceutical organization focused on developing and maintaining labeling strategies for innovative treatments. It offers a globally connected remote work environment that values precision, collaboration, and continuous professional development.
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.
Provide technical and regulatory support to Compliance Managers and Senior Advisors, ensuring product documentation meets client policies.
Prepare, verify, check, and approve product documentation using supplier information, reporting any non-compliance.
Apply client's new and updated policies, regulatory, and technical requirements; maintain awareness of microbiology and nutritional analysis.
SGS is the world's leading testing, inspection and certification company, recognized as a global benchmark for sustainability, quality, and integrity. With 100,000 employees operating across 2,600 offices and laboratories, SGS fosters a culture of trust, reliability, and innovation to enable a better, safer, and more interconnected world.
Lead product safety surveillance strategies and risk management for investigational products.
Oversee medical review of safety data and ensure compliance with global pharmacovigilance regulations.
Build pharmacovigilance infrastructure and manage vendor partnerships as the company grows.
Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. It is a growing biotechnology company with a startup culture focused on making a difference.
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.
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.