New Jersey, USA
US$200000 - US$300000 per annum
11 months ago
*In this leadership role, defines Global Regulatory CMC strategies, deliverables, resource requirement, budgets, and timelines to support product development milestones, from preclinical studies, regulatory filings to support clinical development and registration, to commercialization, and product life cycle management.
*Stays current with global regulatory requirements and new technologies/methodologies in cell and gene related CMC areas that may have regulatory consequences.
*Interacts with regulatory authorities through conferences and regulatory filings/meetings, and anticipates regulatory changes and develops proactive strategy accordingly
*Responsible for supporting and reviewing the CMC sections in regulatory submissions including both pre-approval and post approval submissions such as IND, NDA/BLA, amendments/supplements, annual reports, product characterization study reports, comparability protocols and reports, etc.
*Provides clear and solid regulatory recommendations for facilitating CMC strategies and execution plans in assisting product development teams
*Anticipates regulatory CMC changes and develops proactive strategy accordingly
*Coaches and develops a highly effective and scientifically strong team
*PhD or Master in Life Science (e.g. Immunology, Biochemistry, Biotechnology, Biology) or equivalent
*Minimum of 10 -15 years in the pharmaceutical industry, with a minimum of 8 years CMC regulatory (biologics preferred) experience.
*Cell therapy experience with global CMC regulations and regulatory submissions strongly preferred.
*Excellent working knowledge/experience in regulatory submission and approval processes for cell and gene therapies and product life cycle management and proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements
*Proficient with other international regulations, including ICH guidelines
*Excellent communication and writing skills