Global Regulatory Strategy Lead

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.

We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

Help us lead one of the world’s largest pharmaceutical companies. We are a world leader in plasma‑derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That’s why we need a Global Regulatory Strategy Lead like you.

Leads the R&D Regulatory Strategy group for assigned products 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.

• As Global Regulatory Lead, develops and oversees worldwide regulatory strategies for projects and issues affecting new products or new indication development.
• Leads interactions and negotiates with global regulatory authorities regarding programs and initiatives that significantly impact the business.
• Serves as a resource for other departments inside and outside of R&D on regulatory‑related product development issues.
• Guides, directs, and leads staff, and develops 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.
• 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.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below 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).

• Requires Ph.D., Pharm.
  
  D., M.D. or equivalent.
• 8 years’ direct experience in Medical Research, Clinical, Regulatory Affairs or other critical areas within the pharmaceutical industry.
• Comprehensive knowledge and understanding of FDA and global regulatory requirements for the biotechnology and pharmaceutical industry.
• Deep experience in clinical development, trial design statistical principles is essential.
• 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…