Company Description Hyjawe Pharma focuses on advanced Regenerative Medicine treatments that support doctors in three main areas: aesthetic rejuvenation, women’s gynecological health, and non-surgical orthopedic repair. The company partners with healthcare professionals to deliver therapies that help patients look and feel better while improving overall quality of life. Hyjawe Pharma also provides aesthetic doctors with a comprehensive portfolio of products designed to support clinical success and practice growth. The organization operates at the intersection of innovation, patient care, and physician support, offering a dynamic environment for regulatory professionals.
Role Description The Regulatory Affairs Specialist is a full-time, on-site role based in Amman. This role is responsible for preparing, reviewing, and maintaining regulatory documentation for regenerative medicine and aesthetic products, ensuring alignment with local and international regulatory requirements. Day-to-day tasks include coordinating regulatory submissions, tracking approval timelines, and communicating with health authorities and notified bodies as needed. The specialist will collaborate closely with cross-functional teams such as quality, medical, and commercial to ensure regulatory compliance throughout the product lifecycle. Additional responsibilities include monitoring regulatory changes, supporting audits and inspections, and contributing to internal regulatory policies and procedures.
Qualifications
- * Strong skills in Regulatory Documentation and Regulatory Submissions for pharmaceutical, medical, or regenerative medicine products.
- Solid understanding of Regulatory Compliance and applicable Regulatory Requirements in relevant markets.
- Demonstrated experience in Regulatory Affairs within pharmaceuticals, medical devices, or related healthcare industries.
- Bachelor’s degree in Pharmacy, Life Sciences, Biomedical Engineering, or a related field; advanced degree is an advantage.
- Knowledge of regional regulatory frameworks and familiarity with international guidelines (e.g., EMA, FDA, ICH) is beneficial.
- Excellent attention to detail, organizational skills, and ability to manage multiple submissions and deadlines concurrently.
- Strong written and verbal communication skills in English; proficiency in Arabic is an asset.
- Ability to work collaboratively on-site with cross-functional teams and maintain high ethical and compliance standards.