Senior Director, Regulatory Affairs (CMC)
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POST DATE 9/17/2016
END DATE 10/18/2016
San Diego, CA
JOB DESCRIPTIONThe Senior Director of Regulatory Affairs (SDRA) provides a high-profile opportunity to design and execute the global regulatory plan for Pfenex' products, including biosimilars, therapeutic equivalents and novel vaccines. Working closely with CMC, Quality, Product Development, Clinical Development, Commercial, and Project Management, the SDRA is accountable for the regulatory plan, particularly in areas related to CMC, as well as hands-on management of technical and operational aspects related to regulatory activities. The SDRA has the potential to meaningfully impact the development and adoption of biosimilars and therapeutic equivalents in the United States and around the world.
ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES
Plan, organize and prepare regulatory documents for submissions to regulatory agencies: IND/IMPDs, BPD meeting requests, annual reports, BLA/NDA filings, and other regulatory agency documents as required
Accountable for global CMC plan of programs and contents of Module 3 while ensuring regulatory compliance
Facilitate and lead face-to-face interactions with regulatory agencies
Participate and provide regulatory input/guidance on product development plans
Provide global plan on the implementation of manufacturing changes
Build, motivate and oversee the work of a team of regulatory consultants, advisors and vendors
Establish appropriate risk-based solutions that account for regulatory requirements and develop alternative courses of action, including anticipation of regulatory responses through contingency planning
Work to integrate regulatory CMC requirements and expectations throughout the organization
Review changes in domestic and international laws, regulations and regulatory guidelines to assess impact and make recommendations to ensure compliance.
Maintain regulatory records and files
Manage and participate in selected QA activities
Represent Pfenex regulatory affairs at industry working groups (e.g., Biosimilar Council) as required
Other duties as assigned