Associate Director, CMC Regulatory Affairs will translate regulatory requirements working effectively with the respective process and manufacturing teams to collaborate, implement and interact meaningfully into workable strategies and plans for various stages of drug development of drug substance and drug product. This individual supports CMC regulatory filings for the conduct of clinical trials and registrations in the US and global markets for the development and commercialization of pipeline drugs.
ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES)
CMC Regulatory Associate Director will play a leading role in translating CMC regulatory requirements into practical, workable strategies and plans for development and commercial stage drugs.
• Support the Change control processes and SOP development that related to the Chemistry, Manufacturing and Quality Control of the product
• Implementation of CMC regulatory strategy through the manufacturing and other processes.
• Maintains current knowledge of regulations and guidelines (FDA, EMA, ICH, PMDA and others as required) supports the development and authorship of communications such as regulatory briefing packages.
• Support Good manufacturing practice (GMP) for biologics and combination products and regulatory approval processes
• Reviews Chemistry, Manufacturing and Controls documents with respect to alignment with program strategy and consistency of scientific interpretations/messages, clarity, completeness, and regulatory requirements.
It is each employee’s responsibility to perform their work properly and ensure a product or service meets the current Good Manufacturing Practice (cGMP) requirements for Safety, Identity, Strength, Purity, and Quality. It is each employee’s responsibility to immediately report observations regarding anything that deviates from established standards to their supervisor and to the Quality function.
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented appropriate and clear and conclusions are adequately supported by data.
• Knowledge of biologics drug substance and drug product manufacturing and quality assurance (QA)/ quality control (QC)
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
• Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and strategic in the approach to new and diverse problem solving.
• Common Technical Document (CTD) structure, electronic (eCTD) submission requirements, and electronic document management system (First Doc, Veeva preferred)
• Guidance documents related to CMC for International Conference for Harmonization (ICH)
• Good manufacturing practice (GMP) for biologics and combination products (strongly preferred)
• US and EU Biologics, and Device Development (21 CFR Parts 3, 4, and 800) and Approval process
• Regulations, guidance, and procedures applicable to FDA (CDRH and CDER Office of Pharmaceutical Quality, Office of Biotechnology Products), and EMA (Biosimilars, European Medical Device Directive).
EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL)
• BA in Science with 6-10 years experience in Pharmaceutical Industry (preferably in Regulatory Affairs); OR Ph.D. with 3-5 years of experience in Pharmaceutical Industry (preferably in Regulatory Affairs)