Associate Principal Scientist, Regulatory Affairs

Job Description 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 Associate 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 Associate 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 Senior Scientist / Scientist in support of their assigned projects. The Associate Principal Scientist / Associate Director responsibilities include but are not limited to: Participation in the authorization process to prioritize submissions. In-depth knowledge of global Chemistry, Manufacturing, and Controls regulatory guidelines regarding Investigational New Drug Applications, Biologics License Applications, and 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 Investigational New Drug Applications, Biologics License Applications, and 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 Clinical Trial Applications, Investigational New Drug Applications, Biologics License Applications, and 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. Education Minimum Requirement: B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry. Required Experience and Skills: Prior Biologics Investigational New Drug Application (IND), License Application (BLA) and/or post approval filing experience with at least 10 years subject matter expertise in biologics Chemistry, Manufacturing, and Controls development or manufacturing. Experience in biologics regulatory Chemistry, Manufacturing and Control in both pre-approval and registration required, with experience authoring agency interactions, responses to questions, and Investigational New Drug Application, Investigational Medicinal Product Dossier, and Biologics License Application 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 complex 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. Preferred Experience and Skills: Experience with antibody-drug conjugates (ADCs), combination products and/or complex dosage forms through to commercialization. Preferred fields of study include Microbiology, Virology, Molecular Biology, Engineering or Biochemistry. Required Skills: Adaptability, Adaptability, Biochemistry, Biologics License Application (BLA), Biology, Cognitive Flexibility, Commercialization, Cross-Cultural Awareness, Detail-Oriented, Electronic Common Technical Document (eCTD), Employee Training Programs, International Regulatory Compliance, Lateral Thinking, Next Generation Science Standards, Pharmaceutical Process Development, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance, Regulatory Documents, Regulatory Management, Regulatory Processes, Regulatory Strategy Development, Regulatory Submissions, Regulatory Writing, Scientific Analysis {+ 6 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. 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