Quality & Regulatory Affairs Specialist
Selangor, MY
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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 well-being 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. |
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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.
As a Quality & Regulatory Affairs Specialist, you will play an essential role in supporting regulatory submissions, maintaining product licenses, and ensuring compliance with local and international quality standards. You will also contribute to the continuous improvement of quality systems and support pharmacovigilance activities across various business units.
What your responsibilities will be
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Lead and execute regulatory strategies, product registrations, license maintenance, documentation submissions, and compliance with Malaysian regulatory requirements.
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Coordinate with HQ, regional partners, and authorities; manage packaging artwork, promotional material compliance, and maintain the registration database.
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Support quality systems: documentation control, SOP updates, audits, quality metrics, and management of complaints, deviations, CAPAs, recalls, and lot release processes.
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Ensure alignment with GMP/GDP/ISO standards and contribute to continuous improvement and root‑cause investigations.
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Assist pharmacovigilance activities including safety case triage, post‑marketing surveillance, ICSRs follow‑up, and support PV‑related SOPs.
Who you are
- Degree in Pharmacy and licensed pharmacist status.
- At least 2 years of experience in a similar position within the sector.
- Proficiency in MS Office.
- Strong understanding of GDP, GMP, and ISO quality frameworks.
- Project management skills, effective communication, teamwork, and problem‑solving abilities.
- High ethical standards and commitment to compliance.
What we offer
This is an exciting opportunity for someone looking to grow within a global organization.
- Full-time position based in Petaling Jaya, Malaysia with a hybrid work model.
- Exposure to multi‑business‑unit collaboration (Biopharma and Diagnostics).
- Training and development within quality and regulatory frameworks.
- Collaborative, international working environment.
At Grifols, we support professional growth and career development.
For more information about Grifols, visit www.grifols.com. If you’re interested in joining our company and meet the qualifications, apply today!
Grifols is an equal opportunity employer.
Location: APAC : Malaysia : Selangor:Malaysia