New Zealand Jobs Regulatory Affairs Officer Position at ALPHA LABORATORIES (NZ) LIMITED
- Job vacancies posted on: 10 months ago
Our company is currently seeking employees to fill the position as Regulatory Affairs Officer. For those of you who live in New Zealand and its surrounding areas, we need you to then join and becoming a part of our company to work in our office, ALPHA LABORATORIES (NZ) LIMITED, and able to work under full time system.
As a company that is professional and competent in the field we are engaged in, we have specific criteria for each of our employees as well as the prospective employees. If you are experienced in the field of Sciences & Biotechnology with a minimum degree of , professional, honest and disciplined in work, we look forward to hearing from you as soon as possible.
The average starting salary we can offer you is in the range of RM 1,600 - RM 3,700. If you have credibility beyond the minimum criteria we are looking for, the provisions regarding the average initial salary we offer may change according to our company HRD agreement.
|ALPHA LABORATORIES (NZ) LIMITED
|Regulatory Affairs Officer
|Type of Work
We are looking to hire several Regulatory Affairs Officers. We are a nutraceutical manufacturing company with two manufacturing facilities at Highbrook and Mt Wellington, Auckland. This position is based at one branch, but candidates must be prepared to work at the other branch as well.
The role is to focus on product and raw material registration to ensure that they meet customer requirements. This involves applying scientific knowledge while complying with quality, technical, and regulatory requirements. The role also requires the proactive driving of a culture of GMP for prevention. Additionally, the role is responsible for training and guiding team members to achieve the company’s objectives.
This role will be a permanent, full-time position. Paid fortnightly, 4 weeks annual leave, Statutory holidays, Sick and bereavement leave. Opportunities to upskill.
Candidates need to be able to start immediately and work lawfully in New Zealand.
Successful Candidates are expected to:
· 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 company’s 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 or Pharmacology.
- Minimum of 2 year experience in quality and regulatory matters and product or ingredient registration for target market preferably in SEA, etc
- Candidate must possess good verbal and written communication skills. Ability to read and write in multi language(s) is an advantage
- 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
Candidates must have no history of substance abuse and must have a clean criminal record.
If you are interested in applying this job, please send your CV and cover letter to us
|Alpha Laboratories (NZ) 48 Crooks Road, East Tāmaki, Auckland 2013, Selandia Baru
- Career development opportunities with proven individual
- Detail-orientated with commitment and accountability
- Leading nutraceuticals & food manufacturer
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Alpha Laboratories Ltd is a leading nutraceutical and food manufacturer in New Zealand.
At Alpha, our capabilities along the entire value chain from
initial concept, to formulation, to your packed finished product have been well
recognized through our commercial success. We continue to build on this
success, via ongoing investment in personnel, and unique manufacturing
processes to improve capacity.
With expertise and the latest cutting-edge equipment, Alpha can
offer a wide variety of tailor-made delivery systems. By offering a range of
dosage delivery forms optimized for unique nutraceutical ingredients.
- Industry: BioTechnology/Pharmaceutical/Clinical research
- Registration No.: 9429037663032
- Company Size: 201 - 500 Employees