REGULATORY AFFAIRS and compliance officerINTEGRATED MANUFACTURING SERVICES PROVIDERS, INC.

JOB DESCRIPTION
DUTIES & RESPONSIBILITIES:
1. Responsible with the preparation of regulatory documentation including regulatory submissions, drafting Product information, Consumer Information, literature searches to support submissions, finished product analysis, changes in manufacturing, pack sizes, packaging changes and other regulatory activities.
2. Maintains database with information on registration status of product portfolio.
3. Ensures that the content, organization and overall quality of all regulatory documents and samples are adequate and complies with local regulatory requirements, commitments and agreements.
4. Undertaking and supervising regulatory inspections
5. Coordinating with local regulatory authorities.
6. Coordinating with clients’ Regulatory Officer.
7. Negotiating with regulatory authorities for marketing authorization.
8. Lead and set direction for the sites’ internal and external quality program.
9. Conducts internal audit and provide assistance for 3rd party audits.
10. Monitors CAPA Plan compliance of each department for GMP deviations and findings during internal and regulatory audits.
11. Ensures training has been provided to QA before undertaking specific duties and that all training is recorded in training records
12. Investigation, resolution and management of customer complaints
13. Oversees document control and ensures that QMS and HAS documents are updated, protected and retained.
14. Oversees plant trial, microbiological and stability testing performed by Quality Analyst.
15. Perform other related tasks assigned by immediate supervisor / management.
JOB QUALIFICATION
JOB SPECIFICATION:
5-8 years of experience in Food / Fast Moving Consumer Goods (FMCG) / Medical Device / Pharmaceutical manufacturing or equivalent (relevant to the specialist area of expertise)
College Degree, Science (Biological / Physical / Pharmaceutical / Healthcare)/ Food Technology / Engineering / Manufacturing / higher (Master's / PhD)
PRC license is an advantage.
Knowledgeable in Microsoft Office Suite (Excel, PowerPoint, Word). Excellent organizational, analytical, and problem-solving skills. Strong functional understanding of local and international regulatory programs.
OTHER JOB REQUIREMENTS
Education
Bachelor's/College Degree
Field of study
Science & Technology
Specialization
Manufacturing
Knowledge in MS Office