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Regulatory Affairs and Quality Specialist
Location: Dubai, SA
Contract Type: Regular Full-Time Area: Quality Req Id: 524731
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 affair
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
You will
support the Scientific Office Manager (SOM) in obtaining timely approvals for product registration, re-registration, and variations with the Saudi FDA. You will
actively follow up on submissions to resolve any regulatory issues efficiently. You will
anticipate and respond to regulatory and technical queries from competent authorities. You will
assist in closing deficiencies or observations raised by regulatory bodies. You will
monitor regulatory updates and ensure compliance with new legislation to develop effective regulatory strategies. You will
manage regulatory correspondence between the company and competent authorities. You will
review product artwork and promotional materials to ensure compliance with regulations. You will
liaise with the local Qualified Person for Pharmacovigilance, supporting safety reporting, compliance with local legislation, audits, and inspections. 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:
Education: Bachelor’s degree in Pharmaceutical Sciences.
Experience: 2–4 years in Regulatory Affairs or a related field.
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. #LI-HJ1
#LI-Hybrid
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.
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