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Regulatory Affairs Director

hace 3 semanas

Barcelona, España Instituto Grifols SA A tiempo completo

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 Regulatory Affairs Director like you.

**Mission**

**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.

**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.

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

**#LI-ER1**

**Location**:SPAIN : España : Sant Cugat del Valles**:SC3**

Learn more about Grifols