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.
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.
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.
Lead and manage all drug safety functions for investigational products across the organization.
Oversee pharmacovigilance activities, vendor management, and regulatory submissions.
Collaborate cross-functionally to ensure compliance and advance patient safety.
BridgeBio pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and accelerate innovation. The company focuses on rare diseases with small expert teams and a culture of curiosity and ethical AI use.
Manage safety contract service organizations (CSOs) to ensure ≥95% compliance with global safety regulations and corporate KPIs.
Oversee AE intake from global data sources and prepare assessments of safety data for internal leadership and regulatory authorities.
Maintain audit trail as inspection-ready at all times and direct participation in agency inspections (FDA, EMA, Health Canada, etc.).
BridgeBio Pharma pioneers a pooled risk model for biotech, advancing early-stage research to develop life-changing medicines for rare diseases. They are a multi-state employer with a culture of curiosity, experimentation, and high expectations for their team members.
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.
Lead pharmacovigilance strategies and safety signal detection for Apogee's pipeline.
Collaborate with cross-functional teams to ensure high-quality safety data for regulatory submissions.
Provide medical oversight of safety data and contribute to benefit-risk assessments.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics for inflammatory and immune-mediated diseases. Founded in 2022 and publicly traded, the company operates with a fast-paced culture grounded in C.O.R.E. values: Caring, Original, Resilient, and Egoless.
Develop and evolve a clinical governance framework adaptable across markets, including policies, standards, and oversight structures.
Design quality monitoring programs and track key clinical quality metrics to ensure consistent, safe telehealth services.
Partner with regional teams on regulatory compliance, risk mitigation, and continuous improvement initiatives.
HeliosX is a healthcare platform that makes healthcare faster and more accessible, operating proprietary brands like MedExpress and Dermatica with vertical integration. With over 1.7 million patients treated in 2025 and £781m in revenue, we are a fast-growing, profitable company with a culture of discipline and clinical excellence.
Manage regulatory relationships by coordinating communications and preparing materials for authorities.
Draft and review regulatory correspondence while supporting governance activities and risk assessments.
Track legislative changes and assist with compliance training, reporting, and cross-functional projects.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. They use technology to streamline recruitment and focus on fair, objective candidate evaluation.
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.
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.
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.
Provide subject matter expertise to teams for global disclosure strategies of clinical documents under regulatory requirements.
Manage planning, preparation, and quality control for disclosures, including oversight of vendor deliverables.
Lead development of standard processes and technological solutions to ensure compliance with disclosure regulations.
Pfizer is a global biopharmaceutical company dedicated to discovering and developing innovative therapies. As a large multinational employer with a culture of individual ownership, it employs tens of thousands of people and fosters a collaborative and inclusive environment.
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.
Serve as the primary point of contact for physicians, clinics, and healthcare stakeholders, ensuring consistent communication and trusted relationships.
Support healthcare providers in navigating patient assistance programs, including enrollment, reimbursement, and therapy access processes.
Manage and complete all required documentation such as special authorizations, prescription renewals, and enrollment forms with accuracy and timeliness.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. They use technology to ensure fair and efficient recruitment processes, and foster inclusive employee programs.
Oversee strategic planning and execution of disease monitoring programs for rare diseases.
Collaborate with cross-functional leaders to align evidence strategy and implement best practices.
Represent the DMP function on project teams and mentor personnel working on programs.
Ultragenyx is a biopharmaceutical company focused on rare disease medicine, challenging the status quo to create life-changing treatments. They foster a supportive and inclusive culture with profound learning and growth opportunities for employees.
Lead authoring and development of high-complexity Phase II-IV clinical regulatory documents for a top pharma partner.
Own the end-to-end medical writing process from planning through final delivery, ensuring alignment with strategy and timelines.
Coordinate cross-functional teams across geographies and facilitate comment resolution to drive document development.
Fortrea delivers solutions that bring life-changing treatments to patients faster. They are a global organization that empowers employees to shape their own career path with comprehensive training and management support.
Conduct and report SIV, RMV, COV onsite monitoring visits and perform CRF review, source document verification, and query resolution.
Manage site communication and be the point of contact for in-house support services and vendors, while communicating with internal project teams on study progress.
Support regulatory teams in preparing documents for study submissions and prepare for and participate in audits and inspections.
The company is a dynamic, global mid-size clinical research organization founded in 1995, bringing together more than 3,000 dedicated individuals. They work on the frontline of medical science, changing lives and bringing new medicines to those who need them.