Position: Regulatory Affairs Manager
Total Vacancy: 1 Male/Female
Responsibilities and Duties:
Ø Ensure compliance with GMP regulations for the manufacturing, packaging / labeling, laboratory analysis, and product specific market authorizations.
Ø Corporate liaison for government inquiries into product quality issues as relevant to known or suspected adverse reactions.
Ø A participant in product recalls.
Ø Participate in internal GMP and third party audits.
Ø Write, review, and revise SOPs, corporate policies, procedures, customer methods, product labels (including inserts or tags), and packaging instructions for legal compliance to regulatory and contractual obligations.
Ø Write, review, and revise corporate legal document (however named), including but not limited to Manufacturing Agreements, Quality Agreements, Exclusivity Agreements, Confidentiality / Non-disclosure Agreements, and Product Supply Contracts.
Ø Submit and maintain product applications for market authorizations as required by the health authorities of Brunei, Malaysia, USA, Canada (or other jurisdictions), lending to product specific market authorizations.
Ø As required, provide assistance with the submission or filing of import / export documentation.
Ø Participate in other tasks that may be assigned by the Managing Director.
Ø A B. Sc. degree or equivalent in an applicable discipline of science (chemistry, biochemistry, medicine, or related), or law (administrative, contract, drug, or related).
Ø Three or more years of QC/QA experience in the pharmaceutical/nutraceutical related industry.
Ø Advanced knowledge of GMP and PIC/S regulations from Brunei, Malaysia, USA, and Canada (or other jurisdictions).
Ø Able to work as a team and possess soft skills such as personnel integrity, and interpersonal skills.
Ø Proven ability to supervise personnel and excellent verbal/written communication skills.
Age: 30 - 50 years old
Basic Salary: B$ 3, 000 / Month
Employment Type: Full Time
Closing date: 31/05/2019
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