Regulatory Affairs Officer
14 hours ago
**Job Title: Regulatory Affairs Officer**
**Location: Auckland**
This role will be a permanent, full-time position and will be guaranteed 40 hours of work per week. You will be paid an hourly rate of NZD 29.66 NZD 30.00 depending on your experience and skill level. Paid fortnightly, 4 weeks annual leave, Statutory holidays, Sick and bereavement leave. Opportunities to upskill.
- Ensure compliance with applicable regulatory standards and establish procedures and systems to maintain standards.
- Manage, coordinate, write, and document regulatory processes, including inspections, internal audits, and registrations.
- Assist in obtaining and maintaining authorities approval for therapeutic products, nutritional products, and related materials.
- Compile, maintain, and review registration documentation, including SOPs, raw material specifications, product formulations, market labels, production instructions, and quality records.
- Support out-of-specification events and customer complaints relevant to scientific, technical, and regulatory assessment.
- Prepare technical specifications and testing parameters for laboratory experiments to ensure incoming samples are tested for parameters that meet technical manufacturing needs, target market, and regulatory requirements.
- Administer quality processes and procedures to ensure compliance with applicable regulatory standards and internal guidelines.
- Develop a strong working knowledge of cGMP, health supplements, complementary medicines requirements, and stay abreast of changes to ensure the companys regulatory affairs system remains current.
- Understand all aspects of product development, including clinical trials, research, manufacturing practices, regulations, and authorities approval processes in different markets.
- Strategize to achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, compliance, and technology.
- Conduct risk assessments to ensure compliance and quality standards and proactively drive root cause analysis and effective implementation of corrective and preventative actions.
- Assist in regulatory requirements for marketing claims and labelling requirements for import and export markets.
- Monitor the document management system and review status.
- Ensure effective management of declarations, permits, and regulatory approvals to meet company and regulatory requirements.
- Proactively suggest, design, and prepare regulation requirements for new opportunities as approved by the company.
- Maintain confidentiality of obtained information and implement or distribute relevant documents or work with company approval.
- Perform any other duties and tasks as reasonably requested by the company from time to time.
**To be considered for this position**:
- Tertiary qualification in Food Science, Nutrition, Biotechnology, Chemistry, Pharmacology or equivalent is an advantage.
- Minimum of 1 year experience in quality and regulatory matters and product or ingredient registration for target market preferably in Southeast Asia, China etc
- Proven track record of regulatory experience in food manufacturing environment.
- High attention to details, perform tasks in a methodical and thorough manner within scheduled timeframe and strong drive for improvement.
- Possess excellent teamwork abilities, and organizational skills
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