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 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.
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.
Develop and execute US Medical Affairs strategy for evidence generation across tumor types, collaborating with internal and external stakeholders.
Provide strategic input into Global Integrated Strategic Plan and Plan of Action for ADC portfolio.
Prepare and present scientific data at internal meetings and external advisory boards.
Gilead is a biopharmaceutical company dedicated to advancing innovative medicines for life-threatening diseases like HIV, viral hepatitis, and cancer. With a global presence in over 35 countries, Gilead fosters a collaborative and inclusive culture focused on scientific excellence.
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.
Provide leadership and mentorship across regional clinical trials while ensuring high-quality study execution with minimal travel.
Oversee monitoring visit reports, manage study risks, and ensure compliance with corrective measures at country and regional levels.
Collaborate with cross-functional teams, lead project calls, and deliver training to support data integrity and site performance.
PSI CRO is a privately owned, global Contract Research Organization dedicated to advancing medical science and bringing new therapies to patients worldwide. Founded in 1995, the company has over 3,000 employees and prides itself on long-term stability, having never undergone a merger, acquisition, or company-wide layoffs.
Drive strategic account management for oncology products, ensuring customer engagement and market access alignment.
Lead cross-functional teams to achieve business objectives and expand patient reach.
Develop and implement account plans to maximize product value and growth opportunities.
Bristol-Myers Squibb is a global biopharmaceutical company transforming patients' lives through science. With a large workforce and a culture focused on innovation and inclusion, they prioritize agility and diverse perspectives.
Plan, develop, and oversee scientific content for oncology accounts across multiple therapeutic areas.
Lead client interactions, brand strategy, and the scientific portion of brand planning and business development.
Manage resource allocation, develop SOWs, and identify areas for new and organic growth.
Lockwood collaborates with pharmaceutical, biotech, and medical device clients to develop science-based medical communication strategies. Over a third of its staff hold advanced scientific or medical degrees, and most work remotely, fostering a flexible, work-life balanced 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.
Lead and develop clinical operations teams, overseeing oncology trial execution from feasibility to closeout.
Drive process improvements and operational excellence to enhance study delivery and site performance.
Ensure compliance with regulations, manage budgets and resources, and foster stakeholder relationships.
The company is a global clinical development organization focused on advancing oncology therapies through clinical trials. It fosters a collaborative and inclusive work environment with opportunities for professional growth and continuous learning.
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.
Lead scientific strategy and content development for oncology-focused medical communications programs.
Serve as a senior scientific partner to clients, driving brand planning and new business initiatives.
Manage multiple projects with rigorous editorial standards and cross-functional collaboration.
This role is listed on behalf of a partner company that provides AI-powered job matching services. Jobgether is a platform that uses AI to connect candidates with hiring companies, emphasizing efficiency and objectivity in recruitment.
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.
Execute and support the thought leader engagement strategy for the platinum resistant ovarian cancer asset ELAHERE.
Build long-term relationships with national/regional HCPs to support strategic engagement objectives and foster collaboration.
Oversee regional speaker programs, coordinate TL engagements at medical conferences, and collaborate with cross-functional teams.
AbbVie discovers and delivers innovative medicines and solutions for serious health issues in immunology, oncology, neuroscience, and aesthetics. It is a large global biopharmaceutical company with a culture focused on making a remarkable impact on patients' lives.
Develop high-quality clinical and regulatory documents supporting global submissions
Partner with cross-functional teams to transform complex scientific data into clear narratives
Ensure compliance with regulatory requirements while managing document timelines
Acadia Pharmaceuticals is a biopharmaceutical company developing innovative therapies to address unmet medical needs in neuroscience. With a collaborative and patient-focused culture, the company is committed to advancing treatments that improve lives.
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.
Provide strategic leadership and medical expertise for clinical development of antibody portfolio in IBD.
Lead ongoing Phase 2 platform study and shape registrational program.
Drive cross-functional collaboration and regulatory interactions for global submissions.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation therapies for immunology. It is a young, fast-paced company with a high-growth environment, focused on advancing antibody therapeutics for IBD.
Manage customer accounts and establish products on formularies or contracts in targeted US geographies.
Develop high-level business relationships with executive management and key decision-makers.
Lead account management in contracting, ensuring implementation and compliance.
AbbVie discovers and delivers innovative medicines and solutions in immunology, oncology, and neuroscience, including Allergan Aesthetics products. They are a major pharmaceutical company with a global workforce, committed to diversity and inclusion.