The AD is responsible for Grifols Diagnostic NAT, Immunodiagnostics and Immunohematology businesses, as needed. This position located in San Diego, will mainly be responsible for U.S. submissions.
Supervise and assist in the preparation of regulatory submissions for U.S. and applicable foreign regulatory bodies. Direct various types of regulatory activities including license applications and export applications, as appropriate by product and regulatory strategy.
Participate at the design and development project team level, providing regulatory advice and opinion in the context of issues surrounding new product development and ongoing product support.
Supervise regulatory professionals to achieve the above stated goals.
As part of translation of a design into a manufactured product, lead various types of regulatory activities, license applications and export applications, as appropriate by product and regulatory strategy.
Work cross-functionally with internal and external customers to provide recommendations regarding regulatory requirements, including labeling, to support the global distribution of Grifols products.
Attend relevant industry meetings to keep abreast of changes to regulations affecting business
Monitor and maintain establishment licenses
Key Performance Indicators / Measures for Success:
Effectiveness of team interactions as measured by how timely and effectively information is shared with or obtained from associated project teams.
Effectiveness of management as measured by the effective use of direct reports and project team members.
Effectiveness of proposed regulatory strategies as measure by success of regulatory authority interactions and submissions.
Timeliness of submissions.
Acceptability of submissions.
Bachelor’s Degree in Life Sciences, Physical Sciences or Engineering required/Master’s or Doctoral Degree preferred
Additional trainingin Regulatory Affairs preferred (e.g., Graduate or Certification programs)
Second language preferred, e.g., Mandarin, Spanish
Minimum 6 years direct regulatory affairs experience within the Biologics/IVD/medical device industry
Regulatory affairs managerial experience; strong leadership and mentoring skills
Experience with US/ex-US registration processes and requirements. Knowledge of cGXP, ICH, EU and other international directives and compliance systems.
Background in design and development projects preferred
Strong written, verbal, and interpersonal communication skills. Ability to work independently, as well as in close collaboration. Ability and desire for problem solving and decision-making in a cross-functional team setting
Specific Professional Competencies:
Strategic Skills: Understanding the regulatory landscape and business needs
Understands the regulatory landscape on a global level, understands the current and future business needs, able to articulate changes in the regulatory landscape and how they relate to the business, create regulatory position on changes to the landscape and influence requirements, whenever possible
Organizational Positioning Skills: Comfort Around Senior Management
Can deal comfortably with and influence senior management; can present without undue tension and nervousness; understands how senior management thinks and works; can determine the best way to achieve senior management goals by talking their language and responding to their needs; can craft approaches likely to be seen as appropriate and positive.
Personal and Interpersonal Skills: Collaboration
Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can win concessions without damaging relationships; can be direct and diplomatic; quickly gains trust of others.
Internal Number: 59614
Grifols is a global healthcare company whose mission is to improve the health and well being of people around the world. We accomplish this mission by producing life-saving protein therapies for patients and by providing hospitals, pharmacies and healthcare professionals with the products they need to deliver expert medical care.
Grifols has been working in the fields of transfusion, blood banking, protein therapeutics and laboratory analysis for more than 70 years. Founded in 1940 by Dr. J.A. Grifols Roig, three generations of the Grifols family have led the company ever since. Today, our Grifols S.A. President, Victor Grifols, ensures that the company remains focused on what matters most: People. Our dedication to the advancement of healthcare for humankind is evidenced by our strong global presence: we distribute products in 90 countries.