Grifols Shared Services North America, Inc Associate Director, Regulatory in RTP, North Carolina
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
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.
Primary Responsibilities for role:
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 activites 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 cross-functinoal teams 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 senario 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 and review documents with complex scientific information for regulatory submissions.
Develop and monitor project timelines, and provide leadership cross functions at the level of study teams to ensure quality deliverables within defined timelines
Monitor external vendors
Knowledge, Skills & Abilities:
Knowledge and understanding of global 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.
Bachelor's Degree in a related scientific discipline
12+ years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write comprehensive scientific information for use in regulatory submissions. 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 commerialization/life cycle. Prior experience in bridging several scientific disciplines. Leadership skills within a matrix driven organization.
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 intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
The estimated pay scale for the Associate Director, Regulatory role based in the United States (non-California), is $145,000.00 - $190,000.00 per year. Additionally, the position is eligible to participate in up to 30% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, 9 paid Holidays per year, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
For Washington State:
Currently, the first year PTO accrual for this role is 160 hours per year. Then, after completion of 365 days of employment the PTO accrual for this role will increase to 180 hours per year.
The estimated pay scale for the Director, R&D Regulatory Strategy role based in California, is $167,000.00- $219,000.00 per year.
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.
Learn more about Grifols (http://www.grifols.com/es/web/international/home)
Req ID: 502689
Type: Regular Full-Time
Job Category: Regulatory Affairs