Senior Principal Consultant – Regulatory Affairs

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October 10

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Suttons Creek, Inc.

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Pharmaceuticals • Biotechnology

Suttons Creek, Inc. is a consultancy specializing in the development and commercialization of combination drug/biologic and device products. As part of the ToxStrategies family, Suttons Creek supports pharmaceutical companies by providing expert guidance on strategic planning, device selection, regulatory approval, and commercialization of combination products. With extensive experience from industry-leading pharmaceutical, biotechnology companies, and the FDA, Suttons Creek offers turnkey device execution and consulting services. Their approach enhances the client's value proposition by ensuring efficient product launches that are on time and within budget, ultimately improving profitability and patient impact.

11 - 50 employees

💊 Pharmaceuticals

🧬 Biotechnology

📋 Description

• Provide drug delivery and combination product consulting services as a Suttons Creek team member in areas related to Regulatory and Quality projects as assigned. • Leads teams of assembled consultants to execute on client projects • Develop Regulatory and Quality strategies and execute upon those strategies for drug delivery and combination product companies. • Stay abreast of current industry trends and changes and communicate those to internal Suttons Creek staff and clients • Support with the development of regulatory, quality and engineering business templates, protocols and service offerings for Suttons Creek • Support with identifying and development of new profit centers and client offerings • Support with the identification of potential Suttons Creek consulting talent through regulatory, quality and industry connections • Support with the Suttons Creek Sales Cycle and client procurement • Develops our junior consultants and foster relationships with consultants in unique fields of specialty • Support with developing a strong internal team culture at Suttons Creek

🎯 Requirements

• 7+ years of Regulatory experience with a focus on pharmaceutical-related combination products and/or drug delivery systems • BS in Engineering, Biology, Chemistry, Physics or related Scientific discipline, or equivalent experience • Demonstrated expertise in Pharmaceutical-related medical devices, combination products and/or drug delivery systems- with experience in development and life-cycle management. • Strong understanding of DHF elements, and their integration through the medical device development process. • Understanding of medical device regulations, guidance, and standards • Demonstrated project management skills and leadership abilities. • Direct experience with one or more Autoinjectors, Pre-filled syringe, or on-body delivery systems. • Knowledge and experience authoring and compiling US/EU regulatory submissions for drugs and/or devices ( e.g. NDA, BLA, IND, PMA, 510k, IDE, MAA, CE Mark, NB opinion, Meeting Requests). • Strong written and oral communication skills • Problem solving and critical thinking skills. • Project management skills and knowledge of current project management tools and concepts.

🏖️ Benefits

• Medical and Dental insurance • PTO • 401k