Senior Regulatory Affairs Professional
hace 2 días
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our Biopharma Regulatory department at Grifols, a global healthcare company dedicated to improving the health and well-being of people worldwide. This exciting opportunity offers a unique chance to work on complex submissions and follow-up of product registrations or any other regulatory activity, ensuring timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
About UsGrifols is a leading company in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 110 countries and regions. We value diversity and are committed to equal employment opportunities that foster an inclusive environment.
Your Responsibilities- Prepare, review, and manage complex submissions and follow-up of product registrations or any other regulatory activity: Ensure timely submission, accuracy, comprehensiveness, and compliance with regulatory standards.
- Communicate with affiliates, outside companies, and Health Authorities: Build strong relationships to facilitate seamless communication and cooperation.
- Represent the regulatory function on project teams related to worldwide product registrations: Collaborate with cross-functional teams to drive successful product registrations.
- Maintain tracking of product registrations: Develop and implement effective tracking systems to ensure compliance and efficiency.
- Create regulatory affairs policies and procedures: Establish best practices to ensure regulatory compliance and consistency across the organization.
To excel in this role, you will require:
- A Bachelor's Degree in Life Sciences field (preferred).
- Minimum 2 years of related technical and/or regulatory experience in the pharmaceutical industry or an equivalent combination of education and experience.
- Experience with applicable worldwide regulatory product registrations laws and regulations.
- Advanced level of English language proficiency.
- User of Microsoft Office tools.
This is an excellent opportunity to grow your career in a dynamic and supportive environment. As a Senior Regulatory Affairs Specialist at Grifols, you can expect:
- A competitive estimated salary of $**80,000 - $100,000 per year** based on location and experience.
- Flexible working hours: Monday-Thursday 7-10 to 16-19h and Friday 8-15h.
- An attractive benefits package, including comprehensive health insurance and retirement savings plan.
Join us in our mission to improve the health and well-being of people around the world. If you have what it takes to succeed in this challenging yet rewarding role, we look forward to receiving your application.
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