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.
Lead development and execution of global regulatory strategy.
Act as a subject matter expert in regulatory affairs for product introduction.
Participate in quality system and design dossier audits.
Jobgether is a platform that helps candidates get jobs by using AI-powered matching process. They appear to be a medium-sized company that values speed, objectivity, and fairness in their application review process.
Partner with product managers, designers, engineers, marketers, and researchers in understanding key user needs.
Build user flows, wireframes, prototypes, and high-fidelity designs to communicate solutions to cross-functional partners.
Translate business goals and regulatory constraints into clear, intuitive, and compliant user experiences.
Achieve is a digital personal finance company that helps people move from struggling to thriving by providing innovative and personalized financial solutions. They have over 3,000 employees in mostly hybrid and 100% remote roles across the United States with hubs in Arizona, California, and Texas.
Partner in optimizing and streamlining design control requirements for medical devices.
Lead process development and improvement projects with cross-functional teams globally.
Conduct and develop training on design controls and related process changes.
Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly and fairly. They identify the top-fitting candidates and share this shortlist with the hiring company.
Be the RA representative on core functional teams for advertising and promotion and global software regulatory classification.
Work closely with SW development, engineering, architect, quality and cybersecurity teams.
Represent RA in the assessment of global cybersecurity and data privacy initiatives.
Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). They have broadened their vision beyond diabetes to empower people to take control of their health with personalized, actionable insights. Dexcom has thousands of ambitious, passionate people worldwide.
Lead the company’s U.S. regulatory strategy for digital health, telemedicine, pharmacy, and consumer products.
Oversee all regulatory filings, submissions, and registrations, including FDA establishment registrations and product listings.
Provide regulatory intelligence—monitoring federal and other regulatory activity and synthesizing developments into clear, actionable insights for internal teams.
Hims & Hers is a health and wellness platform with a mission to improve health around the world. They are customer-centric, and focused on affordability, access, and personalized care. Hims & Hers is a public company traded on the NYSE under the ticker symbol “HIMS”.
Provides regulatory guidance throughout the clinical development life cycle.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
Keeps abreast and continually expands knowledge of laws, regulations and guidelines governing drug development and approval.
Precision Medicine Group is a company that works in the clinical trial space. They are an equal opportunity employer that values diversity and does not discriminate based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Own the global clinical supply strategy for late-stage programs.
Manage external partners, including packaging and labeling vendors.
Serve as the clinical supply chain lead on cross-functional study teams.
Jade Biosciences is focused on developing innovative therapies to address critical unmet needs in autoimmune diseases. They are developing JADE101 for the treatment of immunoglobulin A nephropathy (IgAN).
Assist with the implementation of global regulatory roadmaps and marketing strategies.
Advise product design teams on regulatory strategy for new products.
Plan regulatory compliance for new product introductions and changes.
Jobgether uses an AI-powered matching process to ensure applications are reviewed quickly, objectively, and fairly against the role's core requirements. They identify the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
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.
Support registrations, submissions, and lifecycle maintenance activities.
Help maintain and improve QMS processes and records to support ISO 13485 certification.
Receive, log, review, and route product complaints for investigation.
Dandy is transforming the antiquated dental industry through technology. Backed by leading venture capital firms, Dandy is building the operating system for dental offices around the world—empowering clinicians and their teams to achieve more for their practices, their people, and their patients.
Serves as a source of medical expertise for clinical project teams.
Provides medical input into the design, planning, initiation and completion of clinical trials.
Responsible for the preparation of the medical components of study protocols and IND and other regulatory submissions.
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology. They are advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction and seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.
Maintain knowledge of regulations applicable to submissions for medical devices.
Communicate technical and scientific information to project teams and regulatory authorities.
Collaborate with cross functional teams to develop regulatory strategy.
Cook Research Inc. manufactures medical devices and is part of the Cook Group companies. They are committed to equal employment opportunities and value diversity within their workforce.
Author administrative and CMC regulatory documents in collaboration with SMEs.
Manage full CMC submissions, ensuring compliance with requirements.
Jobgether is a company that uses an AI-powered matching process assisting partner companies with their recruitment needs. They aim to ensure applications are reviewed quickly, objectively, and fairly.
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.
Clinical quality compliance oversight for our clinical development programs both in the US and internationally.
Independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.
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.
Set strategy for the domain, translating clinical and product strategy into a technical direction.
Lead managers and teams, build an inclusive culture, and grow future leaders.
Deliver treatment launches with rigor, owning delivery for clinical product initiatives.
Hims & Hers is a health and wellness platform that aims to help the world feel great through better health. They deliver personalized care for results and are a public company traded on the NYSE under the ticker symbol “HIMS” with a talent-first flexible/remote work approach.
Lead Wheel’s commitment to clinical excellence, overseeing programs such as Clinical Protocol Design.
Integrate clinical insights into our virtual care platform, ensuring scalable and safe virtual care delivery.
Define key performance metrics and implement mechanisms to drive continuous improvement across quality, safety, and clinician experience.
Wheel is evolving the traditional care ecosystem by equipping the nation's most innovative companies with a premier platform to deliver high-quality virtual care at scale. They offer proven strategies and cutting-edge technologies to foster consumer engagement, build brand loyalty, and maximize return on investment.
The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA).
The GLL provides both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross-functional stakeholders.
As a core member of the Global Regulatory Team(s) (GRT) for assigned product(s), the GLL ensures that product labeling reflects scientific integrity, regulatory compliance, and patient focus across global markets.
Sobi is dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.