Regulatory Affairs Director
Sant Cugat del Valles, Spain
What your responsibilities will be
- 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
- Oversees a team to ensure 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
Who you are
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.
- 10 years direct experience in Medical Research, Clinical, Regulatory Affairs or other critical areas within the pharmaceutical industry.
- Fluent English
- Comprehensive knowledge and understanding of EMA 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.
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