Regulatory Affairs CMC - Katalyst Healthcares and Life Sciences : Job Details
Regulatory Affairs CMC
Katalyst Healthcares and Life SciencesJob Location : Florham Park,NJ, USA
Posted on :
2025-04-13T15:43:38Z
Job Description :
Responsibilities:
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- 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.
- 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).
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