Serve as primary contact for assigned study sites, ensuring protocol implementation and compliance with ICH-GCP and local regulations.
Conduct on-site and remote monitoring visits, building strong relationships with site staff and resolving operational issues.
Maintain inspection readiness of sites, manage study documentation, and contribute to study performance tracking and recruitment support.
Our partner is a clinical research organization that manages global clinical trials. They offer a collaborative global team environment and opportunities for career development in clinical operations.
Lead batch release activities and provide GMP oversight for manufacturing partners to ensure compliance with global regulations.
Manage investigations, deviations, CAPA, and change controls while supporting audits and inspections.
Mentor and develop junior QA staff and contribute to quality system improvements.
Deciphera is a biopharmaceutical company dedicated to developing innovative therapies for cancer. The company fosters a collaborative culture with opportunities for personal and professional growth.
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.
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.
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.
Prepare and submit regulatory documents to IRBs/ECs and support study start-up activities.
Perform data entry, document cleanup, and QC during migration to Florence eRegulatory.
Maintain CVs, licenses, and GCP documentation, partnering with coordinators, investigators, and sponsors.
UniTriTeam is a global organization that supports clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
Supports the strategy and execution of US Public Affairs activities, with a focus in cystic fibrosis.
Monitors state legislation and identifies substantive policy and political opportunities and risks to the company’s business.
Develops plans, goals, processes, and logistics for projects, gaining cooperation and alignment.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. Vertex is consistently recognized as one of the industry's top places to work, with global headquarters in Boston's Innovation District and international headquarters in London.
Responsible for CMC regulatory activities globally for assigned projects and adapts swiftly to changing events and priorities.
In charge of CMC strategy development, with management support, for CMC submission dossiers to support lifecycle management.
Ensures that information submitted in support of life cycle maintenance applications meets regional requirements, allowing maximum flexibility in supply, manufacturing and quality.
Alphanumeric recruits for one of the largest pharmaceutical companies in the world, headquartered in Montreal, Quebec. They are helping them find a Responsable des affaires réglementaires internationales CMC to work remotely in Quebec or Ontario.
Own the end-to-end lifecycle of FDA premarket applications, with an immediate focus on authoring and steering 510(k) submissions to clearance.
Operationalize and maintain compliance across diverse and intersecting jurisdictions, including FDA (Device, Drug & Compounding) and CMS (CLIA/CAP).
Build and scale the "Technical Playbook" for medical product operations, ensuring the company stays ahead of shifting state, federal, and international regulations.
Hims & Hers is a health and wellness platform committed to better health by offering affordable and personalized care. As a public company traded on the NYSE, they are normalizing health & wellness challenges and innovating on their solutions to make better health outcomes easier to achieve.