Grifols Shared Services North America, Inc Director, R&D Regulatory Strategy in Louisville, Kentucky
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Leads the R&D Regulatory Strategy group in managing regulatory programs in support of R&D activities. Oversees and/or participates in the development and implementation of worldwide regulatory programs for new product or new indication development, and leads interactions with regulatory authorities to expedite approvals. Coordinates department activities with related functions, e.g., Regulatory Affairs, to assure efficient and consistent execution of department functions. Represents the department at senior-level, cross functional teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and adherence to regulatory requirements. Oversees staff to ensure the efficient operations of the function.
Primary Responsibilities for role:
Oversees development and implementation of worldwide regulatory strategies for projects and issues affecting new product or new indication development.
Utilizes scientific training when interfacing with Senior Management of technical areas to guide the scope of experimentation and the selection of data needed to support regulatory submissions
Serves as a resource to other departments inside and outside of R&D on regulatory-related product development issues.
Leads interactions and negotiates with global regulatory authorities regarding programs and initiatives that significantly impact the business.
Guides, directs, and leads staff, and sets department goals in accordance with business priorities. Responsible for training, reviews and development of department members.
Advises Senior Management on regulatory aspects of product development and/or lifecycle management. Identifies business implications of complex regulatory and clinical issues, develops risk mitigation strategies and communicates in a manner that facilitates decision making.
Serves as Grifols regulatory liaison in collaborative projects with other companies
Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.
Manages department resources and budget to meet R&D goals
Requires Ph.D., Pharm. D.,M.D. or equivalent
10 years direct experience in Medical Research, Clinical, Regulatory Affairs or other critical areas within the pharmaceutical industry.
Knowledge, Skills & Abilities:
Comprehensive knowledge and understanding of FDA and global regulatory requirements for the biotechnology and pharmaceutical industry.
Excellent oral and written communication skills.
Strong critical thinking and problem solving skills.
Excellent and demonstrated project management skills.
Ability to negotiate and influence regulatory officials.
Ability to work cross-functionally to effectively implement and oversee R&D regulatory programs.
Ability to evaluate complex issues, develop a plan, 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.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
- This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned and qualifications required may change. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Req ID: 483890