Regulatory Assistant
Quezon City, National Capital Region
Posted today
- Company:
- RBGM Medical Express Sales, Inc.
- Company Description:
- RBGM Medical Express Sales, Inc. has the mission to create partnerships with multinational medical device firms to promote, distribute, and deliver cutting edge products and reliable services to health care units in the Philippines.
- Contract Type:
- Full Time
- Experience Required:
- 1 year
- Education Level:
- Bachelor’s Degree
- Number of vacancies:
- 1
Job Description
1. Assist in the documentation process following the initiation of codes by Sales, Marketing,
and Management, ensuring all preliminary information is accurate and organized.
2. Coordinate with third-party principals to gather required regulatory documents, following up
as necessary to meet deadlines.
3. Document and track all responses received from principals, ensuring all necessary
information is complete for FDA submission.
4. Prepare submission documents under the guidance of the Regulatory Supervisor, ensuring
accuracy and compliance with FDA requirements.
5. Maintain a well-organized database of documents for easy retrieval and submission tracking
throughout the regulatory process.
QUALIFICATIONS:
- Bachelor’s degree holder of Pharmacy.
- With at least 6 months of experience in coordination, document processing is a must. Must also be a licensed pharmacist.
- In-depth knowledge of FDA policies and procedures.
- Understanding of regulatory guidelines and compliance requirements.
- Familiarity with regulatory submission processes and documentation standards.
- Strong organizational and time-management skills.
- Excellent written and verbal communication skills.
- Attention to detail and accuracy in documentation.
- Proactive and resourceful in problem-solving.
- Ability to work independently and as part of a team.
- High level of integrity and professionalism.
