Regulatory Affairs Officer
OLEOFINE ORGANICS (THAILAND) COMPANY LIMITEDChemicals/Petrochemicals, Quality Assurance/Quality Control
11/11/2024
Full Time
3 - 5 Year
Nonthaburi
Bachelor's Degree or Higher
Depend on qualifications and experience
Key Responsibilities:
1. Regulatory Submissions:
- Prepare, review, and submit regulatory documents to FDA, Halal, Kosher authorities.
- Ensure timely and accurate submissions in compliance with local and international regulations.
- Manage the lifecycle of regulatory submissions, including initial applications, amendments, and renewals.
2. Compliance Management:
- Monitor and interpret regulatory requirements and ensure company compliance.
- Develop and implement regulatory strategies to support product development and commercialization.
- Conduct internal audits and inspections to ensure compliance with regulatory standards.
3. Documentation and Record Keeping:
- Maintain comprehensive and accurate records of all regulatory submissions and communications.
- Ensure that all documentation is up-to-date and readily accessible for audits and inspections.
4. Cross-Functional Collaboration:
- Work closely with R&D, Quality Assurance, Manufacturing, and Marketing teams to ensure regulatory requirements are met.
- Provide regulatory guidance and support to project teams throughout the product development lifecycle.
5. Regulatory Intelligence:
- Stay informed about changes in regulatory policies, guidelines, and industry trends.
- Communicate regulatory updates and implications to relevant stakeholders within the organization.
6. Training and Mentorship:
- Provide training and mentorship to junior regulatory affairs staff.
- Foster a culture of continuous learning and improvement within the regulatory affairs team.
Qualifications:
- Bachelor’s degree in Chemistry or a related field. Advanced degree preferred.
- Minimum of 5-7 years of experience in regulatory affairs within the food, feed or cosmetic industries.
- In-depth knowledge of local and international regulatory requirements and guidelines.
- Strong organizational and project management skills.
- Excellent written and verbal communication skills in both Thai and English.
- Ability to work independently and as part of a team.
- Proficiency in regulatory submission software and databases.
- Staff training and development
- Fuel/transportation fees
- 5-day work week
- Social security
- Accident Insurance
- Flexible working hours
- Employee's uniform
- Annual bonus
OLEOFINE ORGANICS (THAILAND) COMPANY LIMITEDจำหน่าย เคมีภัณฑ์, สารเคมี, สารเคมีเครื่องสำอางและอาหาร, สารเคมีใช้ในอุตสาหกรรมพลาสติก, เคมี, เคมีภัณฑ์, เคมีภัณฑ์-ขายส่งและผู้ผลิต
Locationเลขที่ 398 ซอย ศรีสมานพัฒนา4/1(ดำรัสสุข) บ้านใหม่ อำเภอปากเกร็ด 11120
Contact person-
Telephone081-685-5517
Website
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