We are looking for a Regulatory Affairs with 1-2 years of experience to join our team. This role is responsible for ensuring adherence to international and local regulatory requirements, preparing and submitting regulatory documents to regulatory bodies, and providing creative solutions to regulatory challenges.
Responsibilities:
1. Prepare and submit regulatory documents to regulatory bodies, such as product registration, listing, and/or license applications.
2. Monitor product registration and listing status
3. Maintain up-to-date knowledge of international regulations and standards.
4. Analyze regulations and develop strategies for compliance.
5. Develop and maintain relationships with regulatory authorities.
6. Interpret regulations and advise management on regulatory matters.
7. Identify and evaluate potential regulatory risks.
8. Provide guidance on regulatory strategies and compliance issues.
9. Develop and implement policies and procedures for regulatory compliance.
10. Monitor regulatory submissions and ensure timely responses to inquiries.
11. Assist in the preparation of regulatory reports.
Qualifications:
1. Pharmacist in a related field
2. 1-2 years of experience in a regulatory affairs role
3. Knowledge of international regulations and standards
4. Excellent problem-solving and analytical skills
5. Ability to communicate effectively, both verbally and in writing
6. Ability to work independently and as part of a team
7. Proficiency in Microsoft Office applications, including Word, Excel and PowerPoint