Develops and implements worldwide regulatory programs for products in development and, or new indications for marketed products. Participates in the development of and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products. Interacts with regulatory authorities to expedite development programs and initial approvals. Serves as a regulatory representative on senior-level and/or cross functional project teams, applying advanced knowledge of regulations and interpretation of guidelines to assure execution of regulatory strategies and requirements.
Responsibilities Dependent upon level obtained, but not limited to:
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 of drug development programs. Interacts with cross-functional groups to ensure alignment of 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.
Develops and implements worldwide regulatory strategies for clinical/product development projects.
Ensures project teams are kept up to date regarding changes to regulatory requirements for drug development and licensure
Serves as a resource to other departments inside and outside of R&D on regulatory-related product development issues.
May have direct report(s).
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.
R&D Regulatory Manager: Bachelor's Degree in a related scientific discipline plus 8 or more years of experience in a related field.
Deputy Director, Regulatory Coordination: Bachelor's Degree, MS, or PhD in a related scientific discipline plus 10+ years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Ability to manage multiple complex projects and timelines in a matrix team environment. Ability to write and position comprehensive scientific information for use in regulatory submissions. Demonstrated interpersonal skills including strong negotiation skills. Experience in leading regulatory strategies through to commercialization/life cycle. Prior experience in bridging several scientific disciplines. Strong leadership skills within a matrix driven organization.
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.