Lead global clinical regulatory activities including strategy and operations for IND/CTA and BLA submissions, liaison with FDA and other health authorities, and support clinical and marketing objectives to ensure compliance and timely approvals.
The Director of Regulatory Affairs will provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for company's clinical asset candidates.
Responsibilities
This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development of all aspects of company's quality, preclinical and clinical drug development programs, policies and procedures, so that Development teams can meet all objectives within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements.
Develop regulatory strategies for assigned programs in collaboration with Company's Regulatory senior management and by analysis of guidance’s and assessment of drug developed for similar indication to obtain approval of activities in support of Company's development.
Also support marketing objectives within specified timelines Liaison responsible for communication with FDA and other health authorities for assigned programs Manage/lead regulatory activities associated with Company assigned drug development programs. Management of the planning, preparation and submission of licensing applications (BLA/MAA).
Requirements
• Minimum of 10 years of pharmaceutical industry
• 5 years of regulatory experience
• MD, Ph.D. or Pharm D. Required
Benefits
• Medical, Dental, Vision all Start Day One
• 401k @.50 on the dollar up to 10%, Vested in 4 Years
• 810 Stock Options
• 135 Restricted Shares of Stock
• Outstanding Relocation Package
• Cost of Living Adjustments
Similar Jobs
.png)
Artificial Intelligence • Big Data • Healthtech • Machine Learning • Software • Biotech
Lead and define global regulatory strategy for diagnostics and medical devices, drive international submissions and commercialization, ensure compliance and inspection readiness, influence regulatory policy, support executive decision-making, and modernize regulatory processes and systems.
Top Skills:
CapCliaFda 21 CfrFda 21 Cfr Part 11Fda 21 Cfr Part 50Fda 21 Cfr Part 54Fda 21 Cfr Part 56GdprHipaaIch E6 (Gcp)Iso 13485Iso 14971Iso 15189Iso 20916IvddIvdrNext-Generation Sequencing (Ngs)NysdohUk Mdr 2002
Biotech • Pharmaceutical
Lead global regulatory strategy and execution for oncology products, securing IND/CTA approvals and supporting BLA/MAA submissions. Provide regulatory leadership across regions, advise cross-functional teams on regulatory requirements, mentor RA staff, manage labeling activities, and interface with major regulatory authorities to ensure program success.
Biotech
Lead global regulatory strategy and operational oversight for partnered oncology development programs. Manage regulatory submissions (IND/CTA, NDA/MAA/BLAs), health authority interactions, lifecycle management, and cross‑functional alignment to ensure timely study execution and approvals. Provide mentorship, policy interpretation, KPI reporting, and strategic guidance across regions to support onboarding and delivery of external partner assets on the company's clinical development platform.
Top Skills:
Microsoft Office Suite
What you need to know about the San Francisco Tech Scene
San Francisco and the surrounding Bay Area attracts more startup funding than any other region in the world. Home to Stanford University and UC Berkeley, leading VC firms and several of the world’s most valuable companies, the Bay Area is the place to go for anyone looking to make it big in the tech industry. That said, San Francisco has a lot to offer beyond technology thanks to a thriving art and music scene, excellent food and a short drive to several of the country’s most beautiful recreational areas.
Key Facts About San Francisco Tech
- Number of Tech Workers: 365,500; 13.9% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Google, Apple, Salesforce, Meta
- Key Industries: Artificial intelligence, cloud computing, fintech, consumer technology, software
- Funding Landscape: $50.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Sequoia Capital, Andreessen Horowitz, Bessemer Venture Partners, Greylock Partners, Khosla Ventures, Kleiner Perkins
- Research Centers and Universities: Stanford University; University of California, Berkeley; University of San Francisco; Santa Clara University; Ames Research Center; Center for AI Safety; California Institute for Regenerative Medicine
