The individual is expected to actively contribute to the development and implementation of CMC regulatory strategies for commercial drug products and products in clinical development. The individual will also coordinate all aspects of CMC regulatory submissions relevant to the assigned projects or programs and serve as the regulatory CMC representative on project teams.
•Coordinate all aspects of CMC regulatory activities and submissions relevant to the assigned projects or programs and serve as the regulatory CMC representative on project teams; provide regulatory guidance during the review of change controls and deviations.
•Develop CMC submission content in eCTD format.
•Manage and execute submission preparations for global regulatory agencies’ review and approval.
•Interact and work closely with Process Development, Analytical Development, Manufacturing, Quality Assurance, Quality Control and Clinical Development to provide technical, scientific, and regulatory support.
•Review and provide comments on process and formulation development and validation protocols and reports, SOPs, method development and validation protocols and reports, stability protocols, product container labeling, product specifications, comparability protocols and reports, quality agreements, and other related documents.
•Manage technology transfers and insure appropriate communication to regulatory authorities.
•Keep up to date regulatory CMC environment and propose regulatory initiatives and changes to comply with Federal Register and FDA and ICH guidance.
•Interact with FDA and other Regulatory Authorities on assigned projects, as appropriate.
•Review Batch Records, Certificate of Analyses (CoA), and CMC reports including analytical, validation, stability, technical change, out of specification, deviation, investigation, corrective and preventive action reports.
•Prepare, collect, review and assemble technical documentation required for writing annual reports, and CMC sections of IND, NDA, SNDA, and BLA;
•Responsible for writing the CMC sections of the regulatory submissions to global regulatory agencies.
•Manage product technical complaints.
•Assist in conducting on-site technical audit of contract manufacturing facilities.
•Prepare Request for Proposals (RFP) to obtain bids from API suppliers and Contract Manufacturing Organizations (CMO).
•Review supply and quality agreements with contract manufactures.
•Assist in due diligence activities for product acquisition Monitor Federal Register regarding CMC requirements which may impact pharmaceutical drug development and commercial drug products.
•Participate in project teams as a CMC expert.
•Liaise with external companies and internal departments to ensure regulatory alliance.
•Other duties as assigned.
SPECIFIC JOB KNOWLEDGE, SKILL AND ABILITY:
•At least 5 years of experience in pharmaceutical industry; must have experience with writing and preparation of CMC sections of regulatory submissions. Previous experience with manufacturing process and formulation development is a plus.
•B.S. or M. S. in Chemistry, Biochemistry, or other appropriate biological disciplines; advanced degree is a plus.
•Knowledge of the processes of manufacturing of active pharmaceutical ingredient (API) and drug product for chemical and/or biological substances.
•General expertise in process control, analytical testing and validations;
•Knowledge of GLP,GMP, GDP compliance, FDA guidelines and federal regulations.
•Strong analytical and technical problem solving skills. Ability to multi-task.
•Demonstrated leader with the ability to work effectively in a collaborative work environment.
•Strong verbal and written communication skills.