Source Job

• Drive growth of Regulatory Science and Medical Writing services across pharmaceutical, biotechnology, and life sciences clients.
• Lead strategic sales efforts, identify client needs, and partner cross-functionally to deliver tailored solutions supporting regulatory approvals.
• Serve as the primary liaison between client and company for all sales-related activities, enhancing visibility and market presence.

Veristat accelerates life-changing therapies to patients worldwide with more than 30 years of expertise. They have a flexible, inclusive culture with 70% remote workforce and 66% women-led teams, having prepared over 105 approved therapies and delivered over 350 rare disease projects.

• Serve as a regulatory representative on multidisciplinary program teams, supporting health authority interactions and global submissions for biologics in development.
• Contribute to regulatory plans across the product lifecycle, from early clinical development through registration and lifecycle management.
• Manage submission activities including INDs/CTAs, amendments, annual reports, and briefing documents, ensuring compliance with US/EU regulations and ICH guidelines.

Oruka Therapeutics (Nasdaq: ORKA) develops novel biologics to treat chronic skin diseases like plaque psoriasis, aiming for high rates of complete clearance with dosing as infrequently as once or twice per year. As a small startup building its core team, we seek top talent passionate about making a difference and contributing to an engaged, inclusive, and positive company culture.

• Define and execute global regulatory strategies across early- and late-stage development for small molecules and combination products.
• Lead and oversee interactions with FDA, EMA, and other global regulatory agencies.
• Author, review, and submit key regulatory documents, including INDs, CTAs, briefing books, and response packages.

Enveda reinvents drug discovery by harnessing nature's intelligence, identifying new medicines four times faster than the industry standard. The company achieved unicorn status after a $150M Series D in 2025, has an award-winning culture recognized by Newsweek and Forbes, and values creativity, collaboration, and deep respect for each team member.

• Drive regulatory strategies for Expanded Access Programs across global markets, ensuring compliance and patient access.
• Act as a subject matter expert in communications with pharmaceutical clients, health authorities, and cross-functional teams.
• Prepare and submit regulatory dossiers while maintaining up-to-date knowledge of global frameworks.

Jobgether uses AI-powered matching to connect candidates with jobs at partner companies. They are a fast-growing global organization with a dynamic scale-up environment and high autonomy.

• Develops and directs global regulatory strategy to obtain and maintain product approvals across key regions.
• Serves as primary regulatory contact for health authorities and leads cross-functional regulatory sub-teams.
• Identifies regulatory risks and provides strategic guidance for product development and lifecycle management.

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients with severe metabolic and endocrine disorders. It is a publicly traded company driven by scientific innovation, collaboration, and integrity.

• Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in compliance with GCP, ICH, and SOPs.
• Build and maintain strong relationships with investigator sites, providing training and guidance to ensure study quality.
• Support IRB submissions, regulatory documentation, and trial master file quality across clinical programs.

CoMind develops non-invasive neuromonitoring technology for clinical brain monitoring. The company is a cutting-edge startup focused on improving diagnosis and treatment of brain disorders, with a culture that embraces AI in daily work.

• Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
• Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
• Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

• Provide leadership and high-level technical support for research compliance, including reviewing human subjects research submissions and non-research determinations.
• Support project teams with data management plans and ensure compliant closeout of learning activities.
• Collaborate with the IRBhelp team to ensure timely review and feedback on submissions.

Jhpiego is a nonprofit global health organization affiliated with Johns Hopkins University, focused on improving the health of women and families. With a global presence, it operates in challenging environments across Africa, Asia, and Latin America, emphasizing research compliance and program learning.

• Support regulatory and quality processes to ensure compliance with applicable requirements, focusing on product design, development, and manufacture of medical devices.
• Assist in drafting regulatory submissions for domestic and worldwide commercialization and provide guidance on product labeling and lifecycle planning.
• Evaluate regulatory impact of changes, manage product recall activities, and participate in internal and third-party quality audits.

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. The company is dedicated to developing better solutions for life from discovery to diagnosis and fosters an innovative culture for talented individuals to solve tough problems.

• Leads writing and preparing clinical and regulatory documents for drug and device development.
• Coordinates review, approval, and quality control across functions to ensure compliance and timelines.
• Develops knowledge of US and international regulations and participates in process improvements.

AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, neuroscience, and aesthetics. They are a large global biopharmaceutical company committed to having a remarkable impact on people's lives.

• Ensure product claims, labeling, and regulatory documentation meet FDA and FTC requirements for dietary supplements.
• Work cross-functionally with Brand, Product, Quality, and Marketing teams to translate regulatory frameworks into actionable guidance.
• Support GMP compliance, audits, and process improvements to strengthen regulatory operations at scale.

The company is a partner organization managing applications and next steps for a role in consumer health. They are a science-led organization with a growing portfolio of microbiome and nutrition-focused innovations.

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.

ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of new medicines and treatments. As a values-driven company, ICON fosters a culture of integrity, collaboration, agility, and inclusion, employing a diverse workforce.

• Support the development, adoption, and scientific positioning of advanced ADMET prediction software by bridging user needs, scientific insight, and product innovation.
• Present and demonstrate ADMET prediction software to scientific and customer audiences, deliver training sessions, and respond to customer inquiries.
• Translate scientific and user feedback into clear product requirements and feature specifications, and contribute to scientific communication through publications and case studies.

Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. They process applications using their matching system and share top-fitting candidates with employers.

• Monitor and interpret CMS guidance for Medicare, Medicaid, and other healthcare programs.
• Partner with internal teams to ensure compliance with regulations and contract obligations.
• Maintain regulatory tracking documentation and support development of training materials.

HealthEdge provides healthcare software and services to payers and providers. It is a growing company with a focus on compliance and innovation, fostering a collaborative and remote-friendly culture.

• Conduct hands-on compliance audits of digital platforms against global privacy regulations such as GDPR, CCPA, and COPPA.
• Design and execute independent audit methodologies to test user protections, content moderation, and data handling practices.
• Present detailed findings and strategic recommendations to clients and their leadership through executive briefings.

Coalfire solves clients' hardest cybersecurity challenges through advisory, assessment, and automation. They are a team of passionate problem-solvers with offices across the US and UK.

• Serve as the primary compliance advisor for transparency customers, providing guidance on regulatory interpretation and risk mitigation.
• Ensure successful achievement of all reporting metrics and deadlines, establishing KPIs and utilizing project management tools.
• Actively engage in sales and marketing efforts to support customer growth through industry conferences and networking.

MediSpend provides transparency reporting solutions for the life sciences industry. The company fosters a diverse and inclusive culture with employees working remotely across the US, offering competitive compensation and benefits.

• Review customer-facing materials to ensure compliance with legal guidelines.
• Embrace AI as a support tool for marketing review and partner with cross-functional teams.
• Lead documentation of best practices and develop an intake system for requests.

Hims & Hers is a health and wellness platform providing accessible, personalized healthcare from diagnosis to delivery. The company is publicly traded (NYSE: HIMS) and fosters a talent-first, flexible/remote work culture.

• Support payer audits and medical record reviews, ensuring timely submission of documentation.
• Manage medical review requests and appeals associated with CMS contractors and regulatory agencies.
• Review clinical documentation using audit checklists and partner with teams to gather required records.

VitalCaring is a provider of home health and hospice services founded in 2021. They are a growing company focused on quality and compliance, with a mission to deliver exceptional patient care.

• Serve as a clinical subject matter expert supporting product and AI teams to evaluate new features for clinical safety and risk.
• Conduct first-line clinical risk assessments across high-impact areas like documentation workflows and medication management.
• Partner cross-functionally with product, engineering, regulatory, and clinical teams to guide safe innovation throughout the product lifecycle.

Our partner operates in healthcare technology, and we use an AI-powered matching process to connect candidates with roles. The environment is mission-driven and highly collaborative, focusing on improving outcomes across long-term and post-acute care settings.

• Serve as the primary point of contact and partner with investigative sites to ensure high-quality clinical trial conduct.
• Conduct site evaluation, training, monitoring, and closure activities in compliance with regulations, GCPs, and SOPs.
• Utilize risk-based monitoring and site engagement strategies to improve data integrity, compliance, and study performance.

AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. A large global biopharmaceutical company, AbbVie fosters a culture of innovation and integrity to transform patients' lives.