Location: Florham Park,NJ, USA
leading/coordinating execution of (CMC) regulatory filing strategy and managing or supporting regulatory processes to achieve timely approval.
preparing high quality CMC regulatory documents or packages in accordance with company standards and procedures, ensuring thoroughness, accuracy, and timeliness.
building strong collaboration with internal stakeholders, including Regulatory Affairs, Quality Assurance, Technical Operations and Global Supply Chain; providing functional expertise to matrix/cross-functional teams.
maintaining current knowledge of regulatory intelligence and processes that may impact regulatory-CMC planning; and keeping abreast of changes in the regulatory environment to better inform stage-specific CMC requirements for clinical studies.
Requirements:
Regulatory professional with 3+ years of industry experience in pharmaceutical, biotechnology or related industry in CMC, Regulatory, Quality, R&D, and Manufacturing or related, with 2-3 years in Regulatory Affairs-CMC.
Bachelor's degree or equivalent in a related discipline. Science or pharmacist major preferred. An advanced degree in a related discipline is preferred.
Understanding of the U.S. drug laws, FDA regulations and expectations for pharmaceutical products, FDA standards for quality, data requirements and knowledge of the NDA review process.
Experience with small molecule drug development, late-stage drug development, and commercial stage programs is a plus. (knowledge of pharmaceutical development, including drug substance, drug product and analytical methods).