Associate Principal Scientist – Regulatory Affairs, CMC, Biologics

Role Overview

• Responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance.
• Responsible for the preparation and submission of CMC sections for commercial or new biologics products.
• Assist in the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist / Scientist in support of their assigned projects.
• Participation in the authorization process to prioritize submissions.
• In depth knowledge of global CMC guidelines regarding IND/BLAs or post approval changes.
• Completion of detailed, global regulatory assessments according to existing global guidelines and policies and defined timelines.
• Development and execution of detailed, global regulatory strategies for submission and approval of INDs, BLAs or post approval change documentation according to defined timelines.
• Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply.
• Lead authoring of clear, concise and effective IND / CTAs, BLAs or global post approval submissions according to defined timelines.
• Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions.
• Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate.
• Participation in early and late development programs, as well as departmental and cross-functional efforts to improve CMC content or processes may also be required, as needed.

Requirements

• Prior Biologics IND, License Application (BLA) and/or post approval filing experience with at least 10 years subject matter expertise in biologics CMC development or manufacturing.
• Experience in biologics regulatory CMC in both pre-approval and registration required, with experience authoring agency interactions, responses to questions, and IND/IMPD and BLA sections.
• Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills.
• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.

Benefits

• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days