Regulatory Affairs Officer

Buen Bioceuticals (M) Sdn Bhd; Kuala Lumpur; Vor Ort; MYR 70.000 - 110.000; Vollzeit

Zusammenfassung

BUEN BIOCEUTICALS seeks candidates to support regulatory activities across the business’s operations to achieve efficiency while meeting customer expectations and ensuring quality assurance and compliance.

The role covers obtaining approvals, managing permits, labeling and marketing claims across markets, plus documentation, risk assessments, and continuous improvement. Relocation or travel to New Zealand may be required.

Qualifikationen

• Proven experience in regulatory affairs for nutraceuticals and food manufacturing.
• Familiar with product or ingredient registration for target markets in Southeast Asia, China, and the Middle East.
• Audit knowledge or experience would be ideal.

Aufgaben

• Assist in obtaining and maintaining authorities' approval for therapeutic products, nutritional products, and related materials in multiple countries
• Ensure effective management of declarations, import/export permits, license, and regulatory approvals to meet company and regulatory requirements.
• Assist in meeting regulatory requirements for marketing claims and labelling requirements for import and export markets.
• Strategize to achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, compliance, and technology.
• Prepare, compile, maintain, and review registration documentation, including SOPs, raw material specifications, product formulations, stability, market labels, production instructions, and quality records in a timely manner.
• To verify the company’s conformance with quality and regulatory standards and procedures, and that they are operating to a high standard of compliance and other regulations for market access requirements.
• Understand all aspects of product development, including clinical trials, research, manufacturing practices, regulations, and authorities' approval processes in different markets.
• Conduct risk assessments to ensure compliance and quality standards and proactively drive root cause analysis and effective implementation of corrective and preventative actions.

Kenntnisse

Regulatory affairs

Nutraceuticals experience

Quality compliance

Product labeling knowledge

Jobbeschreibung

Seeking candidates able to relocate or travel to New Zealand if required.

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About our Company:

BUEN BIOCEUTICALSsupplies health supplement brands manufactured by ALPHA LABORATORIES (NZ) LTD, a leading nutraceutical manufacturer based in New Zealand.

Role Description:

This role focuses on supporting regulatory activities across the business’s operations to achieve optimal efficiency while meeting customer expectations, as well ensuring continuous improvement of Quality Assurance and operations. This involves applying scientific knowledge while complying with quality, technical, and regulatory requirements.

Key Responsibilities:

Assist in obtaining and maintaining authorities' approval for therapeutic products, nutritional products, and related materials in multiple countries

Ensure effective management of declarations, import/export permits, license, and regulatory approvals to meet company and regulatory requirements.

Assist in meeting regulatory requirements for marketing claims and labelling requirements for import and export markets.

Strategize to achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, compliance, and technology.

Prepare, compile, maintain, and review registration documentation, including SOPs, raw material specifications, product formulations, stability, market labels, production instructions, and quality records in a timely manner.

To verify the company’s conformance with quality and regulatory standards and procedures, and that they are operating to a high standard of compliance and other regulations for market access requirements.

Understand all aspects of product development, including clinical trials, research, manufacturing practices, regulations, and authorities' approval processes in different markets.

Conduct risk assessments to ensure compliance and quality standards and proactively drive root cause analysis and effective implementation of corrective and preventative actions.

Qualifications & Skills:

Proven track record of regulatory experiences in nutraceuticals and food manufacturing environment.

Familiarity with quality and regulatory matters and product or ingredient registration for target market preferably in Southeast Asia, China, Middle East etc.

High attention to detail, ability to perform tasks in a methodical and thorough manner within a scheduled timeframe and possesses a strong drive for improvement.

Knowledge and experience in audit would be ideal.

What We Offer:

Professional development and learning opportunities.

Opportunity to contribute to a growing and reputable organisation.

Collaborative work environment.