Director, Biologics CMC Writing

About Parexel Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care...

MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner, IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market...

Director of Regulatory Affairs (Direct Hire) Salary: $225k to $255k with a 20% Bonus. Location: They would love someone that can be onsite 1 or 2 days a week or a couple times a month. Only East Coasters. NC to Boston. Additional Information and Challenges They are receiving candidates that do not have enough experience or they are Reg Ops and Reg/CMC and...

Department: 106800 Technical Operations Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare...

Remote Full time R12455 The Associate Director, Drug Product & Process Development, will provide technical and strategic leadership for late‑stage drug product development programs, including process characterization, control strategy development, regulatory filings (IND amendments, NDA/MAA), and post‑approval lifecycle management (LCM). This role will...

Department: 106200 Research & Non-Clinical DevLocation: San Diego, USA - RemoteBe a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team

Position Overview Expand relationships that accelerate next‑generation therapies. As FUJIFILM Biotechnologies’ Account Director for Advanced Therapies, you will unlock growth across a portfolio of strategic biopharma accounts—expanding scope, deepening partnerships, and aligning our global network’s capabilities to program needs. You’ll operate...

Position Overview Win the programs that shape tomorrow's therapies. As FUJIFILM Biotechnologies' Business Development Director for Commercial Process Development (PD), you'll own the full Business Development cycle-from identifying and qualifying opportunities to negotiating scope and closing signed contracts-focusing on early‑phase programs that scale...

Department: 106750 Clinical DevelopmentLocation: San Diego, USA- RemoteBe a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.Our...