Regulatory Affairs Specialist
hace 4 semanas
Grifols, S.A is a global healthcare company dedicated to improving the health and well-being of people worldwide. We are leaders in plasma-derived medicines and transfusion medicine with operations in over 110 countries. Our commitment to diversity adds value to our business, teams, and culture.
Job Description
- We are seeking a Senior Regulatory Affairs Specialist to join our Biopharma Regulatory department.
Responsibilities:
- 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.
Requirements:
- Bachelor's Degree in Life Sciences field 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.
What We Offer
A competitive salary of $80,000 - $100,000 per year, plus benefits package and flexible schedule. This is a temporary position #J-18808-Ljbffr.
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