[Hiring] Senior reputed company or reputed company Consultant- Regulatory Affairs @Suttons Creek Inc

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. Role reputed company We are reputed company seeking reputed company member who can serve as critical members of our Regulatory, Technical Services Team in delivering solutions for our reputed company reputed company. In this role you will reputed company the project management and technical work of combination product development and the nuances of this reputed company regulatory environment as you support our clients in bringing life-saving therapies to patients. • reputed company drug delivery and combination product consulting services as a Suttons Creek team member in areas reputed company to Regulatory and reputed company reputed company as assigned. • reputed company teams of reputed company consultants to execute on reputed company reputed company. • reputed company Regulatory and reputed company strategies and execute upon those strategies for drug delivery and combination product companies. • Stay abreast of reputed company industry trends and changes and communicate those to internal Suttons Creek staff and clients. • Support with the development of regulatory, reputed company and engineering business templates, protocols and service offerings for Suttons Creek. • Support with identifying and development of new profit centers and reputed company offerings. • Support with the identification of potential Suttons Creek consulting talent through regulatory, reputed company and industry connections. • Support with the Suttons Creek Sales Cycle and reputed company procurement. • reputed company our junior consultants and foster relationships with consultants in unique fields of specialty. • Support with developing a strong internal team culture at Suttons Creek. • Remote-based with 20-30% domestic/international travel. Qualifications • 7+ years of Regulatory experience with a reputed company on pharmaceutical-reputed company combination products and/or drug delivery systems. • BS in Engineering, Biology, reputed company, Physics or reputed company Scientific discipline, or equivalent experience. • Demonstrated expertise in Pharmaceutical-reputed company medical devices, combination products and/or drug delivery systems- with experience in development and life-cycle management. • Strong understanding of DHF reputed company, and their integration through the medical device development process. • Understanding of medical device regulations, guidance, and standards. • Demonstrated project management skills and leadership abilities. • Preferred: reputed company experience with one or more Autoinjectors, reputed company-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 reputed company project management tools and concepts. Requirements • Office Environment: The physical demands described here are representative of those that must be met by an employee to successfully reputed company the essential functions of this position. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the functions. Benefits • Medical and Dental insurance • PTO • 401k Salary reputed company $170-190k plus 15-20% targeted annual bonus Apply tot his job Apply tot his job Apply To this Job