DirecciónDESCRIPCIÓN DE LA OFERTA
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 Regulatory Affairs Director like you.
Mission
Leads the R&D Regulatory Strategy group 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, , 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.
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 , Pharm. D.,
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.
What we offer
It’s a brilliant opportunity for someone with the right talents.
Grifols understands you want a challenging and rewarding career in a critical function such as Regulatory Affairs. We’ll help you grow professionally.
Information about Grifols is available at ’re interested in joining our company and you have what it takes, then don’t hesitate to apply.
We look forward to receiving your application.
Grifols is an equal opportunity employer.
Flexible schedule : Monday-Thursday 7-10 to 16-19h and Friday 8-15h.
Benefits package
Contract of Employment : Permanent position
Flexibility for U Program : 2 days remote working
