R&D Regulatory Manager

Location: 

NC-RTP, US

Contract Type:  Regular Full-Time
Area:  Regulatory Affairs
Req Id:  510712

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.

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.

 

Primary responsibilities:

  • 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.
  • May supervise staff
  • May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes

 

Additional responsibilities:

Represent R&D Compliance in professional and industry organizations.

 

Knowledge, skills, & abilities:

Knowledge and understanding of FDA 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.

 

Requirements:

Bachelor's Degree in a related scientific discipline plus 8 or more years of experience in a related field. 

 

10+ 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 commercialization/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.

 

Occupational demands:

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.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

 

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.  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.

 

Location: NORTH AMERICA : USA : NC-RTP || NORTH AMERICA : USA : NC-North Carolina:USNC0003 - RTP NC-Research Building 85 

 

Learn more about Grifols