Support and contribute to global regulatory strategies to expedite development and mitigate risks.
Plan, prepare, and coordinate regulatory documents for submissions to global health authorities (INDs, BLAs, MAAs, etc.).
Collaborate with cross-functional teams and support interactions with FDA and other Health Authorities.
Immunovant, Inc. is a clinical-stage immunology company developing targeted therapies for autoimmune diseases. As a rapid-growth biotech startup, it fosters a dynamic, fast-paced, and entrepreneurial environment.
Define and lead global regulatory strategy for clinical-stage radiopharmaceutical programs.
Lead key regulatory submissions including INDs, CTAs, and DMFs.
Serve as primary contact for regulatory agencies and build strong relationships with health authorities.
ARTBIO discovers and develops a new class of Alpha Radioligand Therapies (ARTs) to redefine cancer care. It is a global biotech with offices in Boston, Basel, London, and Oslo, fostering a collaborative and supportive culture.
Provide expert regulatory review of labeling, marketing, and advertising claims for food and dietary supplement products.
Serve as a strategic advisor to clients on FDA and FTC compliance, claim substantiation, and product development.
Lead and develop the Marketing Review Services practice while mentoring future team members.
Distro provides regulatory review services for food, dietary supplement, cosmetic, and OTC industries. They are a remote company with a focus on compliance and client support, fostering a collaborative culture.
Lead global regulatory strategy for assigned programs, overseeing processes and managing risks to achieve successful registration and lifecycle management.
Collaborate cross-functionally with teams including toxicology, pharmacology, and clinical development to support clinical programs and regulatory submissions.
Serve as point of contact with health authorities, interpret regulatory guidelines, and drive innovative approaches to regulatory sciences.
Recursion is a clinical-stage TechBio company that uses AI and technology to decode biology and accelerate drug discovery and development. The company employs hundreds across multiple global offices and values integrity, collaboration, and bold action.
Review creative assets for MLR regulatory compliance, brand standards, and copy accuracy before submission and before launch.
Operate Veeva Vault PromoMats including claims, annotations, references, and 2253 filing packages.
Build and maintain quality standards documentation and coordinate creative workflow with project managers.
Power Digital is an AI-Native Growth Firm that helps leading and emerging brands grow by combining deep vertical expertise and proprietary technology. The company values diversity and a people-first culture, with a team of strategists, creatives, analysts, and technologists.
You will lead global regulatory strategy for drug development programs, focusing on Ex-US health authorities.
You will manage and create high-quality regulatory submissions, including Clinical Trial Applications and Market Applications.
You will collaborate cross-functionally to negotiate optimal development paths and ensure compliance with evolving regulations.
Iovance Biotherapeutics is a biotechnology company focused on developing tumor infiltrating lymphocyte (TIL) therapy for cancer treatment. The company is committed to innovation in cell therapy and has a clinical-stage pipeline.
Lead operational and lifecycle management of Regulatory CMC submissions for cell therapy programs.
Develop and execute global regulatory CMC strategies aligning with program objectives.
Serve as Regulatory CMC lead on cross-functional teams, providing strategic guidance.
BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. It operates as a small, mission-driven company in a fast-paced environment.
Develop and lead integrated global regulatory strategies for I&I pipeline programs.
Serve as primary regulatory strategist and Health Authority relationship lead.
Provide expert guidance on development plan design and filing strategies.
Beeline Medicines is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases. It is a small company backed by world-class investors, with a culture of scientific rigor and operational excellence.
Provides regulatory CMC support for drug-device combination products.
Reviews submission documentation and contributes to global regulatory strategies.
Collaborates with cross-functional teams including device development, quality, and clinical.
Vertex Pharmaceuticals is a global biotechnology company dedicated to developing transformative medicines for serious diseases. With thousands of employees, it fosters a collaborative and innovative culture focused on patient impact.
Review advertising and promotional claims for compliance with FDA, FTC, and state consumer protection requirements.
Evaluate claims for compliance with FDA labeling and promotion requirements, coordinating with Regulatory Affairs.
Serve as a key legal liaison to cross-functional teams on claim and compliance matters supporting clinical trials.
The company is a leading health and wellness platform revolutionizing telehealth for providers and patients alike. It is dedicated to building a diverse and inclusive workforce.
Provide regulatory guidance throughout the clinical development lifecycle and prepare quality regulatory submissions.
Compile, coordinate, and review applications to regulatory authorities, including CTA/IND and amendments.
Represent Global Regulatory Affairs at project team and business development meetings, overseeing Regulatory Affairs Specialists.
Precision Medicine Group is a life sciences company providing clinical research, regulatory, and commercial services to biopharmaceutical clients. It fosters a collaborative, quality-focused culture and is an Equal Opportunity Employer.
Lead regulatory and quality strategy for product development and lifecycle management.
Coordinate regulatory submissions and maintain documentation for SaMD products.
Support design change assessments and ensure compliance with FDA, EU MDR, and ISO 13485.
Oura empowers people to own their inner potential through its award-winning Oura Ring and connected app, providing daily insights on readiness, activity, and sleep. As a quickly growing health technology company, Oura fosters a culture of empowerment and well-being, ensuring team members have the resources to do their best work.
Lead the creation of top-notch social strategies and content plans, ensuring high-quality social media management and strategic consultation.
Guide clients and teams on social media strategies, providing expert insight on platform capabilities and FDA/FTC regulations.
Spearhead innovation by exploring new approaches and services to enhance the agency's social media offerings.
Inizio Evoke is a health and life sciences agency that aims to make health more human. They provide a flexible work environment, great compensation, and outstanding company-paid benefits.
Provide compliance review and guidance on marketing campaigns and public-facing materials.
Partner with cross-functional teams to identify and mitigate compliance risks early.
Stay up-to-date on regulatory developments and translate requirements into business guidance.
BHG Financial provides innovative financial solutions for high-earning professionals and small businesses. The company has an award-winning culture centered around transforming talented employees into effective business leaders.