Responsible for submission planning and management of IND-related activities, including annual reports, DSURs, and CTA activities.
Manages the compilation, QC, and submission of INDs, BLAs, and amendments, and prepares routine regulatory documents.
Represents Regulatory Affairs on cross-functional teams, providing expertise and managing submission trackers.
Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer. It is a small, fast-paced company with a collaborative and innovative culture.
Coordinate and track international regulatory submissions for IVD products in the EMEA region.
Manage regulatory release of products using the GTS tool and ensure compliance with IVD/medical device regulations.
Collaborate with global teams to document regulatory assessments and oversee channel partner licenses and renewals.
Agilent provides life science, diagnostic and applied market laboratories with instruments, services, consumables, applications and expertise. With 18,000 employees worldwide, the company fosters a culture of trust, respect, integrity, and inclusivity.
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.
Provide strategic regulatory input and manage European Clinical Trial Applications (CTA) and amendments.
Serve as key regulatory liaison for multi-continental oncology projects, collaborating with cross-functional teams.
Maintain expertise in GCP, EU regulations, and support business development activities.
Theradex Oncology is a full-service CRO specializing in early and late-phase oncology trials globally. Founded in 1982 with over 40 years of experience, the company has managed more than 250 trials and partners with the National Cancer Institute, maintaining a focused culture on cancer drug development.
Lead internal audits, gap assessments, and action item closure for periodic QMS reviews
Manage and maintain design and development files for FDA regulated products
Build and refine quality systems and SOPs in line with cGxP, ISO 13485, and other applicable standards
UpDoc builds the first clinically validated, physician-supervised AI agents that manage chronic diseases. Founded by Stanford physicians, it is an early-stage startup focused on bringing its AI-powered platform to patients and providers.
Manage regulatory activities for complex submissions across EU, GCC, and Australian markets.
Conduct regulatory research, gap analyses, and prepare submission components.
Provide regulatory expertise within multidisciplinary project teams and support business development.
The company provides regulatory consulting services for healthcare products, focusing on global markets. It fosters a collaborative, inclusive culture with opportunities for career development and meaningful impact.
Assist in preparing and reviewing regulatory submissions and manage transmission through FDA ESG.
Maintain submission archive, trackers, and regulatory document templates.
Collaborate with cross-functional teams on product labeling and ensure compliance.
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. We are a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives.
Provide strategic regulatory leadership for companion diagnostics (CDx) and precision medicine programs across global markets.
Lead consulting engagements, guiding clients through FDA, EU IVDR, and international regulatory pathways from development to commercialization.
Mentor consulting team members and contribute to a collaborative regulatory practice focused on precision medicine innovation.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. It operates remotely with a focus on efficiency and data privacy.
Develop and implement global CMC regulatory strategies for biologic and combination products.
Prepare and manage CMC submissions, briefing documents, and health authority meeting packages.
Serve as the CMC Regulatory lead on cross-functional project teams and support health authority interactions.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. The company is a small, dynamic organization with a collaborative culture and a strong focus on regulatory excellence.
Lead the preparation of complex clinical and regulatory documents including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures.
Collaborate with clinical development teams and stakeholders to produce accurate, compliant, and scientifically robust documentation.
Manage document timelines, review cycles, and project deliverables while ensuring quality standards and regulatory requirements are met.
Our partner is a specialized medical writing team supporting the development of high-quality regulatory documentation for the global pharmaceutical industry. It offers a collaborative, remote environment focused on quality, precision, and scientific communication.
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.
Manage day-to-day administration of document control and Quality Management System processes at Noctrix Health.
Serve as primary administrator for controlled documents, training records, and eQMS ensuring compliance and inspection readiness.
Collaborate cross-functionally with Quality, Regulatory, Engineering, and Operations to support QMS effectiveness and improvement.
We are redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience.
Serve as the CDx regulatory subject matter expert, developing global regulatory strategies for companion diagnostics and clinical trial assays.
Lead interactions with regulatory authorities and direct the preparation of global submissions, including FDA Q-Submissions, IDEs, PMAs, and EU IVDR applications.
Partner cross-functionally with pharmaceutical and diagnostic clients to align diagnostic development with therapeutic milestones and commercialization objectives.
Precision Medicine Group provides regulatory consulting services to pharmaceutical, biotechnology, and diagnostic clients, specializing in companion diagnostics and precision medicine. The company fosters a collaborative, client-focused culture with a team of regulatory experts.
Manage the intake, review, analysis, and reporting of Individual Case Safety Reports (ICSRs) and support Clinical Events Committees and Data Monitoring Committees.
Co-author and maintain study-specific safety documents and prepare aggregate safety reports for regulatory submission.
Collaborate with sponsors, study teams, and cross-functional partners to ensure data quality and compliance with GCP and GVP standards.
This partner company delivers high-quality safety services across clinical research and medical device programs. They foster a collaborative, detail-oriented environment with a focus on compliance and patient outcomes.
Critically evaluate scientific literature and produce accurate regulatory documents.
Manage writing assignments across multiple projects and ensure timely delivery.
Work directly with clients and multidisciplinary teams on regulatory submissions.
A partner company in the pharmaceutical, biotechnology, and medical device sectors is hiring a Senior Medical Writer. The company offers a fully remote environment and opportunities to work on a broad portfolio of clinical and regulatory documents.