Provide regulatory affairs support for FDA medical device compliance, including pre-market submissions (510(k), PMA), post-market surveillance, and quality system audits.
Collaborate cross-functionally with R&D, Quality Assurance, and Sales to ensure compliance with U.S. FDA and international regulations (ISO 13485, MDSAP, EU MDR).
Perform regulatory documentation and submissions for new products and changes, and handle customer complaints, field actions, and risk assessments.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions spanning diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, and in-vitro diagnostics. The company is part of Fujifilm, which has over 70,000 employees globally and fosters a dynamic, flexible environment focused on innovation and collaboration.
Manage the development, implementation, and administration of global compensation and benefit programs.
Own and manage HR metrics, reporting, and project leadership for HR operations.
Ensure compliance with federal, state, and local compensation and benefit laws and regulations.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and increasing duration of life for patients with serious unmet medical needs. The company has multiple global Phase 3 clinical studies and is headquartered in Miami, Florida, with additional offices in the US, UK, and Ireland, and its team is driven by core values of integrity, passion, and collaboration.
Ensure marketing, educational, and communications materials comply with FDA, FTC, USP, and state pharmacy regulations.
Lead cross-functional content reviews and provide practical, risk-based compliance guidance to teams.
Develop compliance SOPs, training resources, and auditable documentation to support scalable content operations.
Strive Pharmacy is a personalized compounding pharmacy that creates custom medications tailored to individual patient needs. The company is a growing team focused on disrupting the pharmaceutical industry with a human-centered approach and a collaborative culture.
Collaborate with departmental leads to build project briefs and develop creative strategies.
Lead and mentor the art team while ensuring the quality of all art assets produced.
Build strong client relationships by presenting creative concepts and driving marketing initiatives.
P10 is a remote-first pharmaceutical marketing agency that focuses on delivering exceptional value to clients. The company is composed of diverse, remote-only seasoned professionals with a culture of challenging the status quo and fostering creative excellence.
Lead Medical Affairs workstreams including KTL engagement, congress activities, and scientific communications.
Develop and execute strategic medical plans, translating scientific evidence into actionable recommendations.
Provide scientific expertise across the product lifecycle, supporting clinical education and evidence communication.
Kaléo is a pharmaceutical company focused on developing life-saving auto-injector devices for patients. They are a lean, cross-functional organization with a passionate, purpose-driven culture and a highly collaborative, close-knit team.
Support the development and execution of clinical regulatory strategies for assigned programs across regions.
Prepare and manage IND applications and other regulatory submissions, ensuring accuracy and timely delivery.
Provide regulatory guidance to cross-functional teams and participate in health authority interactions.
Zai Lab is an innovative, research-based biopharmaceutical company based in China and the US, focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients worldwide. Founded in 2014, Zai Lab has a global team of approximately 2000 employees and is committed to gender diversity and environmental responsibility.
Track program performance, manage scorecards, and prepare executive-level updates and decision-support materials.
Our partner company is a technology organization that manages global partner programs across multiple regions. They operate with cross-functional teams and focus on data-driven growth and collaboration.
Own regulatory review and approval of promotional materials across HCP, DTC, digital, and social channels, ensuring compliance with FDA regulations.
Partner with Commercial, Medical Affairs, and Legal to shape campaigns and claims, providing clear guidance to reduce approval delays.
Lead FDA promotional submissions, monitor regulatory trends, and build scalable processes to support product launches.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company values Trust, Ownership, Curiosity, and Results, and offers a collaborative, high-achieving environment with a focus on diversity and inclusion.
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.
Develop high-quality, medically accurate promotional content for pharmaceutical clients.
Conduct literature reviews and manage multiple projects with strict deadlines.
Collaborate with multidisciplinary teams and mentor junior staff.
The company is a medical communications agency that supports pharmaceutical and life sciences clients with promotional and medical content. It fosters an inclusive and collaborative workplace committed to equal employment opportunity and professional growth.
Oversee quality compliance for combination products, ensuring regulatory standards and company objectives are met.
Develop and implement quality strategies in collaboration with cross-functional teams and external partners.
Stay current with global device and combination product regulations, supporting audits and design control oversight.
Vera Therapeutics is a commercial-stage biotechnology company focused on transforming medicine in autoimmune disease, starting with the kidney. Founded in 2016 and based in Brisbane, California, the company fosters a culture of empathy, urgency, and an owner's mindset.
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 strategic and scientific leadership for patient-centered outcomes engagements, ensuring research design and evidence packages are fit-for-purpose.
Owns client relationships, drives business development, and leads proposal development to achieve revenue and sales targets.
Oversees clinical outcome assessment projects including literature reviews, gap analyses, regulatory strategy, and dossier development.
Lumanity is a global strategic partner that brings together strategy, evidence, engagement, and technology to improve health outcomes. The company is dedicated to accelerating and optimizing access to life-changing medicines.
Creates and executes the study TMF Plan and ensures team understanding of expectations.
Monitors and reports on TMF Health to internal team and sponsor, identifying trends and risks.
Serves as point of contact for audits and inspections, and supports process improvement initiatives.
Precision for Medicine is a clinical research organization that provides services for drug development, including trial management and regulatory compliance. The company fosters a collaborative environment with a focus on quality and innovation.
Lead drug product CMC strategy for small molecule programs from early to late stage.
Oversee formulation, process development, scale-up, technology transfer, and validation.
Manage CDMOs and external partners to ensure quality, timelines, and supply continuity.
Our partner is a biotechnology company focused on advancing small molecule drug product development. They operate in a fast-moving, highly outsourced environment with a collaborative, patient-focused culture.
Drive sales force effectiveness by managing and implementing sales systems, processes, and initiatives such as National Sales Meetings and offsites.
Translate brand performance into actionable sales strategies and tactics, and serve as sales liaison with Sales Operations.
Collaborate with Sales and Marketing leadership to develop and implement sales force communication plans.
AbbVie is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines in immunology, oncology, and neuroscience. We are a large organization with a collaborative culture focused on making a remarkable impact on patients' lives.
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.
Provide final signatory approval of promotional and non-promotional materials in line with the PMCPA Code of Practice.
Support brand teams and ensure compliance with ABPI, MHRA, and international codes.
Act as a subject matter expert and confidently present code cases to encourage team learning.
AbbVie discovers and delivers innovative medicines and solutions in immunology, oncology, neuroscience, and aesthetics. As a global biopharmaceutical company, it operates with integrity, drives innovation, and fosters an inclusive culture.
Lead a team of Family Support Educators to provide disease state and product education to Rett syndrome families.
Serve as primary escalation point and collaborate with cross-functional teams including sales, medical, and advocacy.
Drive strategic initiatives and ensure compliance with company policies and patient privacy regulations.
Acadia Pharmaceuticals is a global biopharmaceutical company focused on developing and commercializing innovative therapies for central nervous system disorders, including Rett syndrome. The company is committed to patient support and employee well-being, fostering an inclusive and diverse culture.