Principal Scientist/Director, Regulatory Affairs-CMC (Chemistry, Manufacturing & Controls)

Job Description

As the Director/Principal Scientist in Devices and Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You will spearhead regulatory activities for Devices and Drug-Device Combinations (DDDC), ensuring compliance with domestic and international regulations and guidance. This role includes the comprehensive preparation and submission of combination product sections for both commercial and investigational products, such as pre-filled syringes and autoinjectors. 

Primary responsibilities include, but are not limited to:

• Serve as the Regulatory Project Lead for assigned device and combination products, guiding cross-functional teams to ensure regulatory compliance throughout development and commercialization. Mentor team members while driving project timelines and fostering a collaborative environment

• Maintain in depth knowledge of global device and drug/biologic-device combination product guidelines and policy regarding IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE markings.  

• Lead the development, communication, and review of Regulatory Strategies and execute on various deliverables for submission and approval of complex INDs, BLAs original NDA/MAA, agency background packages, post-approval submissions/variations, and replies to health authority questions according to defined timelines.

• Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions

• Partner with Device Development, Device Quality, and other Drug stakeholders to communicate and align on new regulations and requirements to ensure internal procedures and processes are compliant for the combination product. Participate in activities and teams related to device and combination products

• 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

• Careful planning, tracking, and communicating regarding submissions and approvals to support continued product supply.

• Participate in early and late development programs, as well as departmental and cross-functional initiatives aimed at improving combination product content or processes, as needed.

• Manage or mentor junior team members as needed.

Education: 

• B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemical, Mechanical and Electrical Engineering, Biology, Microbiology,  or Biochemistry.

Required Experience and Skills: 

• A minimum ten (10) years of industry / regulatory experience (5 years with an advanced degree) in pharmaceutical, medical device or combination product research, development and/or manufacturing

• Experience in CMC regulatory (IND, CTA, BLA, MAA) with a drug-device product, preferably an autoinjector

• 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. 

• Superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.

Leadership Skills

• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders

• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events

• Demonstrated effective leadership, communication, interpersonal and negotiating skills in particular with cross functional partners and health authorities

Preferred Qualifications: 

• Subject matter expertise in the regulatory development and manufacturing of auto-injector combination products

• In-depth knowledge of the design control process.

• Preferred fields of study include Biology and Biochemistry.

• Experience