Regulatory Affairs and Quality Specialist 524731

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 wellbeing 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.

Role Mission

As a Regulatory Affairs and Quality Specialist, you will act as a link between the company and regulatory authorities, ensuring that products are manufactured and distributed in compliance with applicable regulations and planned timelines.

What your responsibilities will be

1. You will support the Scientific Office Manager (SOM) in obtaining timely approvals for product registration, reregistration, and variations with the Saudi FDA.
2. You will actively follow up on submissions to resolve any regulatory issues efficiently.
3. You will anticipate and respond to regulatory and technical queries from competent authorities.
4. You will assist in closing deficiencies or observations raised by regulatory bodies.
5. You will monitor regulatory updates and ensure compliance with new legislation to develop effective regulatory strategies.
6. You will manage regulatory correspondence between the company and competent authorities.
7. You will review product artwork and promotional materials to ensure compliance with regulations.
8. You will liaise with the local Qualified Person for Pharmacovigilance, supporting safety reporting compliance with local legislation, audits, and inspections.
9. You will support the renewal of office licenses and ensure compliance with scientific office requirements.

Who you are

To perform this job successfully, you must meet the following requirements:

1. Education: Bachelor's degree in Pharmaceutical Sciences.
2. Experience: 2-4 years in Regulatory Affairs or a related field.
3. Skills:
   • Strong knowledge of regulatory requirements and compliance.
   • Excellent communication and stakeholder management skills.
   • Ability to work in a fast-paced international environment.
   • Detail-oriented with strong problem-solving abilities.

What we offer

This is a great opportunity for someone with the right skills and mindset. You will be part of an international environment with opportunities to grow professionally in a critical function.

Information about Grifols is available at www.grifols.com. If you're interested in joining our company and you have what it takes, then don't hesitate to apply.

We look forward to receiving your application.

Grifols is an equal opportunity employer.

Location: Riyadh, KSA

For regulatory reasons, you must strictly be a Saudi national.

#LIHJ1

#LIHybrid

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic or status protected by law. We will consider for employment all qualified applicants in a manner consistent with the requirements of applicable state and local laws.

Location: EMEA: United Arab Emirates: Dubai: Dubai

Learn more about Grifols.