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.
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.
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.
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.
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.
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.
Set submission strategy and operational timelines.
Build, evolve, and manage the Regulatory Operations infrastructure.
Establish and oversee training on RA procedures and submission standards.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company.
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.
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.
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.