Associate Principal Scientist (Associate Director), Device CMC Regulatory (Hybrid)

Job Description

This Associate Principal Scientist position is equivalent to an Associate Director position.

Under direction from a Director, the Associate Principal Scientist is responsible for implementing regulatory strategies for our organization in accordance with domestic and international regulations and guidance for combination products (Drug and Drug Device combinations).  The Associate Principal Scientist is responsible for the preparation and submission of combination product sections for commercial or new products such as pre-filled syringes and autoinjectors. The Associate Principal Scientist will lead the development and the implementation of regulatory strategies for their assigned projects and provide mentoring and coaching to Sr. Scientist / Scientist. 

The Associate Principal Scientist responsibilities include but are not limited to:

• In depth knowledge of global drug and combination product guidelines regarding IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE marking, ISO and responses to health authority questions per established business processes and systems.   
• Development, communicate, implement and maintain detailed, global regulatory strategies for submission and approval of complex INDs, BLAs original NDA/MAA, agency background packages, post-approval submissions/variations, and responses to health authority questions according to defined timelines.
• Lead authoring of clear, concise and effective INDs, BLAs original NDA/MAA, agency background packages, post-approval submissions/variations, according to defined timelines.
• Provide detailed, global regulatory assessments for changes to device and drug-device combination products according to existing global guidelines and policies and determine and communicate the regulatory reporting requirements.
• Support device design control activities and documentation reviews
• Provide evaluations of regulatory state of affairs of any devices and combination products, for due diligence of potential suppliers, partners, or acquisitions.
• Assess global device and combination product regulatory intelligence and assist in the development of combination product regulatory strategies.
• Participate in activities and teams related to combination products
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
• Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply.
• 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 DQR (Device Quality and Regulatory) leadership team as appropriate.
• Participation in early and late development programs, as well as departmental and cross-functional efforts to improve combination product 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 Biology, Microbiology, Biochemistry, Chemical and Mechanical Engineering,

Required Experience and Skills: 

• Industry / regulatory experience in pharmaceutical or combination product research, development and/or manufacturing
• Experience with CMC regulatory where drug is the primary mode of action (IND, CTA, BLA, MAA)
• 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 neg