Under the direction of the Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing global CMC strategies across product life cycles & execution in North America. Provide collaborative support for execution of global strategies to other regions (EU & International). Manage submissions with the CMC submission group and lead interactions with the FDA and Health Canada for CMC issues. Provide support to other HA interactions as required.
Provide regulatory support, guidance and expertise to internal and external groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned. Provide leadership and submission strategy in the preparation of US and Canada and other global applications in a timely manner to meet corporate objectives.
Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives.
% of Time
Job Duty and Description
Develop global CMC regulatory strategy and manage regulatory activities and timelines for one or more investigational and marketed products
Collaborate within the GRT with GRLs, EU & International regulatory colleagues in development of global CMC regulatory strategies.
Provide leadership and submission strategy in the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies.
Provide strategy and input within the TOPT teams for the assigned programs. Provide CMC regulatory guidance to project / product teams.
Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology or related pharmaceutical field. Minimum of 8years experience in pharmaceutical product development including significant experience in CMC regulatory affairs with a strong biologics background or equivalent. Experience in directing interactions with regulatory authorities desired. Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance
Ability to manage complex projects, timelines and teams in a matrix team environment. Excellent analytical and communication skills – both verbal and written. Ability to communicate effectively to multiple levels of the organization with strong negotiation skills.
With the assistance of a Director or Senior Director, responsible for providing strategic regulatory guidance and timelines to establish key objectives for products. Ability to integrate regulatory strategy into overall product timelines. Responsibility for providing regulatory decisions regarding internal and external negotiations on product development and maintenance strategies.
Significant coordination with cross-functional teams internally and regulatory authorities externally.
Req ID: R0020564