Principal Scientist (Director) - Regulatory Affairs-CMC

Job Description

Director, Combination Product Regulatory CMC - (R5)  

This Principal Scientist position is equivalent to a Director position. Under direction from the Combination Product Regulatory CMC Team Leader, the Principal Scientist is responsible for executing in the Regulatory CMC space.  Leveraging demonstrated capability in Regulatory CMC, this candidate will contribute to and implement Device and Drug-Device Combination regulatory strategies for our organization in accordance with domestic and international regulations and guidance.  The Principal Scientist is responsible for the preparation and submission of combination product sections of regulatory submissions, correspondences, etc. for commercial and development products.  Focus of support will be most often with sterile injectables; pre-filled syringes and/or autoinjectors.   The successful candidate will lead the development and the implementation of regulatory strategies for their assigned projects and provide mentoring and coaching to the larger team.  

The Principal Scientist responsibilities and skills include but are not limited to: 

• Serve as a Combination Product Regulatory Lead and provide leadership within Regulatory and cross-functional teams for assigned products and projects.

• Lead the development, communication, and review of Regulatory Strategies and execute on various deliverables for submission and approval of complex investigational new drugs (IND), biologic license applications (BLA), original NDA/MAA, agency background packages, post-approval submissions/variations, and responses 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 in the area of combination products. 

• Resolve complex project issues through collaboration with the team and cross functional partners and provide recommendations to Regulatory leadership as appropriate. 

• 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.  

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

• Participation and leadership in departmental and cross-functional efforts to improve combination product content or processes may also be required.  Provide evaluations of regulatory state of affairs of any devices and combination products for due diligence of potential suppliers, partners, or acquisitions. 

• Manage or mentor junior team members, as warranted. 

Education Minimum Requirement: 

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

Required Experience and Skills: 

• Demonstrated experience in a CMC regulatory role, with a successful track record executing on regulatory CMC deliverables (IND, CTA, BLA, MAA) with a drug-device product. 

• A minimum ten (10) years of industry / CMC regulatory experience (5 years with an advanced degree) in pharmaceutical or combination product research, de