Specialist - Regulatory Affairs
Julphar
Date: 11 hours ago
City: Ras al-Khaimah
Contract type: Full time
At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.
- Responsible for the overall compilation of regulatory submissions to the Health Authorities, drafting Product Information, Clinical Information, literature searches to support submissions, product analysis, changes in manufacturing, pack sizes, CPI and PIL development, packaging changes, notification and other regulatory activities.
- Prepare and submit the Registration dossiers for the health authorities in different countries as per their current guidelines.
- Respond to the queries received from the health authorities. 4. Review of outsourced registration dossier
- Review of open part API drug master file (APIDMF)
- Coordinate with the regulatory agents in countries, distributors, and other departments concerned with fulfilling the registration requirements.
- Update the product-specific APQR sheet, which comprises complete approved information related to the product at the time of approval in the related market.
- Ensure that all state and International regulatory requirements are addressed for the marketed products and New Product submission.
- Monitor proactively relevant governmental bodies to identify changes in legislation/regulations.
- Maintains knowledge of the current regulatory guidelines environment by reviewing and communicating current decrees policies/practices issued by Health Ministry.
- Maintain up-to-date documentation within the regulatory database
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