Associate Director / Director, Regulatory Affairs

**Associate Director / Director, Regulatory Affairs at Treeline Biosciences in Watertown, Massachusetts** **What you'll do** - Oversee and manage global regulatory activities to ensure compliance with applicable laws - Prepare and manage regulatory submissions including INDs, NDAs, BLAs, briefing books - Partner with Technical Operations to facilitate CMC gap analyses and regulatory impact assessments - Develop and implement standard operating procedures and best practices **What they're looking for** - Experience in regulatory affairs with knowledge of FDA and other global health authority requirements - Ability to collaborate cross-functionally with internal teams - Strong project management skills and ability to manage regulatory budgets - Experience with developing regulatory strategy plans **Details** - Location: Watertown, Massachusetts, United States - Type: Not specified - Salary: Not specified

Ähnliche Stellen in Watertown, Massachusetts, United States

• Medical Director - Hematology — Treeline Biosciences (Watertown, Massachusetts, United States, United States)
• Director, Pharmacovigilance - Treeline Biosciences, Watertown, MA — Treeline Biosciences (Watertown, Massachusetts, United States, United States)
• Clinical Pharmacology Director at Treeline Biosciences — Watertown, MA — Treeline Biosciences (Watertown, Massachusetts, United States, United States)
• Senior / Principal Scientist, Biochemistry — Treeline Biosciences (Watertown, Massachusetts, United States, United States)
• Director, Biostatistics — Treeline Biosciences (Watertown, Massachusetts, United States, United States)
• Medical Director Jobs at Treeline Biosciences — Watertown, MA — Treeline Biosciences (Watertown, Massachusetts, United States, United States)
• Senior Clinical Trial Manager — Treeline Biosciences (Watertown, Massachusetts, United States, United States)
• Clinical Biomarkers Lead — Treeline Biosciences (Watertown, Massachusetts, United States, United States)