Regulatory Affairs Expert: Transforming Healthcare
hace 23 horas
Grifols, S.A
About Us:
We are a global healthcare company dedicated to improving the health and well-being of people worldwide. Our commitment to diversity and equal employment opportunities fosters an inclusive environment.
Job Summary:
We are seeking a Senior Regulatory Affairs Specialist to join our Biopharma Regulatory department. As a key member of our team, you will play a crucial role in preparing, reviewing, and managing complex submissions and follow-up on product registrations or any other regulatory activity.
Responsibilities:
* Prepare, review, and manage complex submissions and follow-up on product registrations or any other regulatory activity, ensuring timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
* Communicate effectively with affiliates, outside companies, and Health Authorities.
* Represent the regulatory function on project teams related to worldwide product registrations.
* Adapt licenses to current regulations.
* Maintain tracking of product registrations.
* Support other departments, affiliates, and third parties in required regulatory information.
* Create regulatory affairs policies and procedures.
Requirements:
* 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.
What We Offer:
A brilliant opportunity for you Grifols is fully aware that its employees are one of its major assets. We maintain an atmosphere that encourages all employees to develop their professional careers in an excellent working environment.
Compensation and Benefits:
An estimated annual salary of $83,000 based on the job requirements and market standards. Flexible schedule from Monday-Thursday (7am-10pm) and Friday (8am-3pm). Comprehensive benefits package.
About Grifols:
Information about Grifols is available at www.grifols.com.
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