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.
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.
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.
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.