We're looking for a Director of Regulatory Affairs (CMC), working in the Biotechnology/Medical Devices industry in Alameda, California, United States.
Represents the Regulatory Affairs department in multi-disciplinary teams to establish CMC regulatory strategies for early and late stage development programs and post-approval changes.
Guides the development, planning, and execution of regulatory submission strategies in line with corporate and program goals and timelines.
Leads and manages submissions to regulatory authorities, tracking progress of review, coordinating responses to questions, and closing out required actions.
The pay range we are offering is 155,000 to 195,000 per year.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
BS/BA degree in related discipline and ten years of related experience. Or MS/MA degree in related discipline and eight years of related experience. Or PhD in related discipline and five years of related experience.
Experience in oncology drug development
Experience with small and large molecules
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.