Senior Regulatory Affairs Specialist
hace 2 semanas
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.
We are looking for a Senior Regulatory Affairs Specialist to join Biopharma Regulatory department.
What your responsibilities will be
- Prepare, review, and manage complex submissions and follow up of product registrations or any other regulatory activity, ensuring timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Communicate with affiliates, outside companies and Health Authorities.
- Represent the regulatory function on project teams as related to worldwide product registrations.
- Adapt licenses to current regulations.
- Maintain tracking of product registrations.
- Support other Departments, Affiliates and Third Parties in any required regulatory information.
- Create regulatory affairs policies and procedures.
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.
- Bachelor's Degree in Life Sciences field is preferred.
- Minimum 2 years of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of education and experience.
- Experience with applicable worldwide regulatory product registrations laws and regulations.
- Experience of eCTD/CTD submissions, and dossier lifecycle management.
- Advanced level of English.
- User of Microsoft Office tools.
- You are meticulous and detail-oriented.
- You have excellent communication and teamwork skills, as well as initiative and results orientation.
What we offer
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, 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: Temporary position
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