Job Description & Requirements
Key Responsibilities :
- Assist in preparing and submitting regulatory filings and documentation for pharmaceutical drugs.
- Support investigation of regulatory compliance gaps with gap remediation plan development and implementation thereafter.
- Determine regulatory relevance and perform variation assessments.
- Maintain and update regulatory files and records as required.
- Ensures compliance with local regulations, corporate policies, and procedures
- Collaborate with cross-functional overseas teams including R&D, clinical affairs, and marketing to support regulatory and QA objectives.
- Ensure that all sales and supply of medicinal products comply with legal requirements:Records pertaining to all phases of drug receipt, supply, storage and distribution are maintained as required by the company and/or legal authorities.
Performs inspections of drug storage area.
Qualifications & requirements:
- Degree in Pharmacy
- Registered with the Singapore Pharmacy Board
- Meticulous and well-organized
- Good communications skills
- Able to work independently
- Ability to meet deadlines
- Proficient in MS Office