Serve as a subject-matter expert on global clinical and regulatory writing projects
Lead the writing, review, and coordination of complex documents such as CTD Modules, Clinical Study Protocols, and Clinical Study Reports
Drive development of key clinical documents that align with overall program and submission strategy
Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly, objectively, and fairly. Their system identifies the top-fitting candidates and shares this shortlist directly with the hiring company.
Define and execute global CMC regulatory strategies for investigational and marketing applications.
Lead preparation, review, and approval of CMC sections for regulatory submissions.
Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.
BridgeBio is a biopharmaceutical company focused on discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases. They employ a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation.
Develop and lead the enterprise compliance strategy aligned with institutional growth plans and regulatory expectations.
Oversee preparation and submission of substantive change applications and institutional reporting requirements.
Establish enterprise compliance training framework for corporate and campus leaders.
Cotulla Education transforms lives through hands-on, career-focused education. They empower students to achieve their professional dreams in high-demand fields. With experienced faculty providing personalized support, their graduates emerge as future leaders ready to make a significant impact.
Serve as primary operational lead and chair for both PRC (promotional) and MRC (medical) workflows.
Oversee development-to-distribution workflows for all approved print and digital materials.
Build and maintain scalable SOPs, workflows, templates and governance frameworks.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company, preparing for its first commercial launch, with an entrepreneurial culture and a focus on establishing foundational capabilities for commercialization.
Develop submission strategies and plans for post-approval CMC activities.
Assess change controls and provide regulatory assessments of quality changes.
Coordinate submission preparation with various departments.
Parexel is a leading global clinical research organization (CRO) providing insights-driven clinical and consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge, they work in partnership with biopharmaceutical leaders, emerging innovators and sites.
Responsible for delivery of site activation readiness within the assigned country/sites.
Preparation of Clinical Trial Application Forms and submission dossier for submission to CA, EC, and other applicable local bodies.
Act as SME for collection and maintenance of site level critical path to Site Activation data points.
Precision Medicine Group is an organization that works in the medical field. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Global Regulatory Lead for a cutting edge RPT programs
Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
Lead the preparation and submission of regulatory filings
RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, develops transformative radiopharmaceutical therapies. They blend the spirit of an emergent biotech with the expertise and resources of a leading innovator in oncology, fostering a multidisciplinary team where ideas are valued.
Perform independent, accurate, and timely management of submissions/transactions/inquiries.
Provide advanced regulations resource for research oversight committees.
Work with leadership to identify, develop, and implement continuous training.
Oregon Health & Science University is committed to innovation in healthcare, education and research. They value a diverse and culturally competent workforce and are an equal opportunity and affrimative action employer.
Serve as key person between Medical Affairs and cross-functional partners.
Proactively identify inefficiencies and duplication of effort across Medical Affairs.
Maintain and continuously optimize Medical Affairs SOPs and policies.
EyePoint is a patient-centric and award-winning ophthalmology company that focuses on science and innovation to offer a lifetime of clearer vision. They specialize in sustained-release treatments for serious retinal diseases and empower curiosity and innovation in a science-based entrepreneurial culture.
Lead and oversee end-to-end clinical trial operations from study start-up through close-out.
Develop and execute operational plans, timelines, and performance metrics to support successful delivery of assigned studies.
Proactively identify operational risks and implement mitigation strategies to maintain timelines, quality, and compliance.
Centessa Pharmaceuticals plc is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data-driven decision-making led by subject matter experts. Their asset-centric model offers a unique R&D logic that has been applied by single-asset companies to improve productivity.
Managing tasks/processes and providing expert guidance on activities related to the design, development, and clearance of new products and product modifications.
Ensuring that new products and documentation are compliant with applicable quality and regulatory requirements.
Serving as the department expert and advisor on specialized activities such as Pre-Submissions, 510(k) submissions, PMAs, and post-clearance activities.
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. They are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity.
Partner with GXP business leaders and translate objectives into comprehensive IT roadmaps.
Oversee selection, implementation, and validation of critical GXP systems.
Drive IT readiness for commercial launch including system scalability and disaster recovery.
Nuvalent is dedicated to creating selective medicines with the goal of addressing the needs of patients with cancer, leveraging deep expertise in chemistry. They are an early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
Collaborate with Clinical Operations, Clinical Development, and other departments on Risk Based Quality Management.
Identify and evaluate the remediation of fundamental risks and quality issues at vendors and clinical sites.
Develop and implement inspection readiness plans and procedures for Health Authority inspections.
Kailera develops therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, Kailera is expanding and seeking talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join the team.
Responsible for timely and quality delivery of site activation readiness, mitigating risks.
Prepare Clinical Trial Application Forms and submission dossiers for regulatory bodies.
Maintain project plans, trackers, and regulatory intelligence tools.
Precision for Medicine is a Clinical Research Organization with an integrated offering that combines clinical trial designs, operational and medical experts, and biomarker and data analytics solutions. They have a passion for rare diseases and oncology, and are growing their team.
Provide senior strategic Regulatory CMC leadership across Antares’ portfolio.
Advise on CMC readiness for INDs and global CTAs, ensuring alignment with clinical development plans and corporate objectives.
Guide the integration of CMC regulatory considerations into early development, manufacturing, and supply decisions.
Antares Therapeutics is focused on bringing transformative oncology therapies to patients. They operate with cross-functional teams including Global Regulatory Affairs, Technical Operations, Quality, and Supply Chain to meet corporate objectives.