Provide strategic and technical leadership for CMC activities, overseeing technology transfer, scale-up, and cGMP manufacturing for small molecule drug development.
Manage contract manufacturing organizations and author regulatory submission sections to ensure alignment and timely achievement of program milestones.
Collaborate cross-functionally with Quality, Regulatory Affairs, and Supply Chain to support clinical and commercial goals from Phase I through commercialization.
Travere Therapeutics is a biopharmaceutical company dedicated to identifying, developing, and delivering life-changing therapies for people living with rare disease. The company is a dedicated team focused on meeting the unique needs of rare patients, fostering a collaborative, diverse, and fast-paced environment centered on patients, courage, community, and collaboration.
BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines for genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has a portfolio of 20+ drug development programs and offices in the US, Canada, and Switzerland, focusing on scientific excellence and rapid execution.
Lead operational oversight of clinical external manufacturing for drug product, transitioning monoclonal antibodies into scalable processes.
Develop robust aseptic strategies for vial and prefilled syringe formats, managing CMOs and technology transfers.
Collaborate with formulation and device teams to create stable high-concentration liquid formulations and troubleshoot manufacturing issues.
We develop potentially best-in-class therapies for patients with severe autoimmune diseases. Our lead antibody, claseprubart, is engineered for extended half-life and improved potency, and we are building a culture centered on core principles to elevate patient care.
Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Lead DMPK and PK/PD strategy across discovery and development programs from candidate nomination through clinical development and regulatory submission.
Drive clinical pharmacology strategy including dose finding, exposure–response modeling, PK/PD analysis, and risk-benefit assessment for early- and late-stage programs.
Provide scientific and regulatory support for DMPK, Clinical Pharmacology, and Biopharmaceutics sections of regulatory submissions, including IND, NDA, and BLA filings.
Enveda is reinventing drug discovery by harnessing nature's intelligence to identify new medicines four times faster than the industry standard. The company achieved unicorn status following a $150 million Series D funding round in 2025 and has been recognized by Newsweek, Forbes, and Fast Company for its award-winning culture.
Lead and manage all drug safety functions for investigational products across the organization.
Oversee pharmacovigilance activities, vendor management, and regulatory submissions.
Collaborate cross-functionally to ensure compliance and advance patient safety.
BridgeBio pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and accelerate innovation. The company focuses on rare diseases with small expert teams and a culture of curiosity and ethical AI use.
Lead integrated drug development strategies across preclinical, clinical, regulatory, and commercial dimensions for pharmaceutical and biotech programs.
Provide expert guidance on clinical development plans, target product profiles, study designs, and regulatory submission strategies.
Engage with global regulatory authorities and support portfolio management, licensing, and business development decisions.
Jobgether uses AI-powered matching to connect candidates with hiring companies. They process applications efficiently and share shortlists with employers, supporting a global, inclusive work environment focused on innovation.
Leads writing and preparing clinical and regulatory documents for drug and device development.
Coordinates review, approval, and quality control across functions to ensure compliance and timelines.
Develops knowledge of US and international regulations and participates in process improvements.
AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, neuroscience, and aesthetics. They are a large global biopharmaceutical company committed to having a remarkable impact on people's lives.
Define and execute global regulatory strategies across early- and late-stage development for small molecules and combination products.
Lead and oversee interactions with FDA, EMA, and other global regulatory agencies.
Author, review, and submit key regulatory documents, including INDs, CTAs, briefing books, and response packages.
Enveda reinvents drug discovery by harnessing nature's intelligence, identifying new medicines four times faster than the industry standard. The company achieved unicorn status after a $150M Series D in 2025, has an award-winning culture recognized by Newsweek and Forbes, and values creativity, collaboration, and deep respect for each team member.