Job Summary
We are seeking a Regulatory and Compliance Associate to ensure the company’s adherence to government regulations for products and facilities. This role involves managing product registration documentation (e.g., PIF for FDA), interpreting regulatory guidelines, participating in project teams for export and labeling compliance, and evaluating the impact of new laws on company activities.
Key Responsibilities
- Regulatory Compliance: Represent the company in complying with government regulating bodies’ requirements for products and facilities (excluding local permits).
- Documentation & Registration: Check necessary documents and create Product Information Files (PIF) for FDA product registration.
- Product Development Understanding: Understand all aspects of product development, including research, clinical trials/tests, manufacturing practices, regulations, and approval processes.
- Project Team Participation: Participate with project teams on regulatory requirements for export, labeling, or clinical study compliance.
- Guidance & Interpretation: Provide and explain regulations, policies, or procedures, and identify/interpret regulatory guidelines.
- Law Evaluation: Evaluate applicable laws and regulations to determine their impact on company activities.
- Documentation Coordination: Coordinate regulatory documentation activities.
Qualifications
- Education: Licensed Pharmacist or Chemical Engineer.
- Experience: Relevant years of related work experience.
- Skills: Proficient in oral and written communication; Computer literate.