R&D Regulatory Specialist - KORE1 Technologies
Los Angeles, CA
About the Job
KORE1, a nationwide provider of staffing and recruiting solutions, has an immediate opening for R&D Regulatory Specialist.
Summary: 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. Job Duties: • 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. Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies. • 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. Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans. • 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. Job Requirements: • 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. Understanding of global regulatory regulations. • Excellent oral and written communication skills. Critical thinking and problem-solving 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. Prior experience in bridging several scientific disciplines. • Leadership skills within a matrix driven organization.
ABOUT KORE1
Specializing in professional and technical recruiting, KORE1 is committed to supporting top IT, Engineering, Creative, Scientific, Accounting and Finance professionals in their career paths. We build deep relationships with leading companies, connecting them to exceptional talent every day. With extensive industry expertise and unmatched opportunities, our goal is to provide a unique experience for our contractors and consultants as they prepare for their next role. We are passionate about matching the right people with the right companies.
Specializing in professional and technical recruiting, KORE1 is committed to supporting top IT, Engineering, Creative, Scientific, Accounting and Finance professionals in their career paths. We build deep relationships with leading companies, connecting them to exceptional talent every day. With extensive industry expertise and unmatched opportunities, our goal is to provide a unique experience for our contractors and consultants as they prepare for their next role. We are passionate about matching the right people with the right companies.
Kore1 provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kore1 complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Kore1 expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Kore1's employees to perform their job duties may result in discipline up to and including discharge.
Source : KORE1 Technologies
