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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Handle new registrations, lifecycle management, and renewals of biologicals, vaccines, and other pharmaceutical products.
Contribute to the preparation and delivery of regulatory submissions from a global and regional perspective.
Prepare and review Marketing Authorization Applications & Variations for multiple regions.
Jobgether is a platform that connects job seekers with employers, leveraging AI to streamline the hiring process. They focus on ensuring fair and efficient candidate evaluation, emphasizing data privacy and objective matching of applicants to roles; their team uses AI tools to support recruitment but makes the final decisions.
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.
Lead the preparation and review of clinical study reports, protocols, and other regulatory documents.
Perform medical writing tasks of high complexity and critical importance to ongoing projects.
Collaborate with cross-functional teams to gather and synthesize information for document development.
Jobgether uses an AI-powered matching process to ensure your application is 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.
Act as Local Contact Person for Pharmacovigilance for the designated country.
Develop strategy and manage set up activities.
Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.
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.