Associate Principal Scientist (Associate Director) - Regulatory Affairs - CMC, Biologics

MSD•Cambridge, MA

5d•Hybrid

About The Position

Associate Principal Scientist, Regulatory CMC - Biologics (R4) This Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from Director/Executive Director, the Assoc Principal Scientist is 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. The Assoc Principal Scientist is responsible for the preparation and submission of CMC sections for commercial or new biologics products. The Associate Principal Scientist will 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. The Associate Principal Scientist / Assoc Director responsibilities include but are not limited to: 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

Nice To Haves

Experience with ADCs through to commercialization
Preferred fields of study include Microbiology, Virology, Molecular Biology, Engineering or Biochemistry

Responsibilities

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.