Regulatory Officer (Pharmacist) APPLY NOW
We are looking for “Regulatory Officer Pharmacist”. Experienced candidates are encouraged to apply.
Job Description:
- Compile and maintain regulatory documentation databases or systems.
- experienced in CTD dossiers preparation
- Have knowledge of international regulatory authorities for preparation of documents for export purposes.
- Develops strategies to ensure the company’s production activities comply with government regulations.
- Serves as a liaison between regulatory bodies and operating divisions of the company.
- Prepares and submits applications and reports to applicable regulatory agencies.
- Responds to requests for information from regulatory bodies.
- Coordinates with operations departments regarding product design and development to ensure compliance with regulations.
- Assists with the development of standards for the company’s operating and production procedures.
- Maintains current knowledge of regulations applicable to the company.
- Monitors regulatory affairs and the effect changes will have on company operations.
- Develops and maintains professional relationships in federal, state, and local regulatory agencies.
- Performs other related duties as assigned.
Skills:
- Documentation
- Knowledge of International Standards
- English Proficient
Min. Qualification: Pharm-D
Experience: 2-3 year