Regulatory Affairs Specialist jobs in United States

Company Description

Protectol Health is a pharma-tech company that focuses on conventional pharma medicines, nutraceuticals, nutrients, and business safety. The company operates with separate divisions for Pharma, Technology, Neutraceuticals, and Business Safety, engaging in effective research and development activities.

Job Responsibilities

1. Prepare and maintain product registration, manufacturing site registration, and DDC and HAAD registration.
2. Support or coordinate with external regulatory affair service providers who can provide relevant expertise.
3. Monitor and analyze changes in regulatory requirements and guidelines.
4. Develop and implement regulatory strategies for product development, registration, and post-approval activities.
5. Stay updated with all applicable laws and regulations related to pharmaceutical products.

Requirements

1. A bachelor's degree in pharmacy, pharmaceutical sciences, or a related field.
2. UAE Regulatory Expertise.
3. Expertise in medical insurance registration.
4. Past experience and knowledge in facilitating guidelines on UAE GMP and EU GMP.
5. Expertise in MOHAP registration.
6. Knowledge of International Regulations.
7. Adaptability and compliance mindset.
8. Leadership and teamwork skills.