R&D Regulatory Specialist

KORE1, a nationwide provider of staffing and recruiting solutions, has an immediate opening for R&D Regulatory Specialist.

• Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements.

• Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products
• Provides regulatory expertise to Research and Development to support the design and analyses of projects.

• Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions.
• Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business.
• Advises Management on regulatory aspects of product development and/or lifecycle management.

• Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.
• Writes documents with complex scientific information for regulatory submissions.

• Bachelor's Degree in a related scientific discipline with at least 4+ years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry.
• Knowledge and understanding of FDA and EU regulations for the biotechnology and pharmaceutical industry.

• Excellent oral and written communication skills.

• Demonstrated project management skills.
• Ability to interact with regulatory officials.
• Ability to evaluate complex issues and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives.
• Ability to work within a global team framework and multi-cultural environment.
• Ability to write comprehensive scientific information for use in regulatory submissions to the FDA and EU.
• Ability to manage multiple complex projects and timelines in a matrix team environment.
• Demonstrated interpersonal skills including negotiation.
• Ability to execute regulatory strategies through to commercialization/life cycle.

• Leadership skills within a matrix driven organization.