We’re looking for an experienced Regulatory Affairs Specialist to join our Auckland-based team.
This is a hands-on and varied role where you’ll support customers with product registrations, new product development and ongoing regulatory compliance across New Zealand and international markets. Working across our own brands and contract manufacturing customers, you’ll collaborate with a wide range of internal and external stakeholders to navigate regulatory requirements and keep products moving
About the role
This role plays a critical role in ensuring our products comply with all regulatory requirements. As a Regulatory Affairs Specialist, you will be responsible for navigating complex regulatory landscapes, supporting customer submissions, and ensuring our products meet the highest standards of safety and quality. This position is fundamental to our company’s success, enabling us to bring quality healthcare products to market while maintaining full compliance with regulatory requirements.'
Key responsibilities
Support the regulatory assessment of raw materials, formulations, specifications, labels and advertising to ensure compliance for relevant customers and markets.
Support the NPD process by working closely with key strategic internal partners
Coordinate and provide regulatory documentation and responses to regulatory requests and queries from customers to support their product registrations and renewals, including MPI Free Sale Certificates/Registration statements, relevant NZHM certifications and technical documentation
Prepare new factory registrations and listing as required ie. for GACC China
Ensure current factory registrations and plant listings are maintained ie. GACC China, FDA, Korea etc.
Monitor relevant national and international regulatory alerts, guidance and developments, assess their potential impact, and communicate relevant changes to internal and external stakeholders in a timely manner.
Coordinate the notarisation and authentication of regulatory documentation where required for customers.
What we're looking for
Tertiary qualification in pharmacy, pharmaceutical science, biomedical science, chemistry or related discipline
3–5 years of professional experience in regulatory affairs within the pharmaceutical or medical device industry
Demonstrated knowledge of regulatory frameworks applicable to pharmaceuticals and medical devices, particularly in Australasia
Strong understanding and experience with regulatory submissions to New Zealand authorities
Excellent written and verbal communication skills with the ability to translate complex regulatory requirements into clear guidance
Proficiency in regulatory information management systems and Microsoft Office applications
Detail-oriented approach with strong organisational and project management capabilities
Ability to work independently and collaboratively within a multidisciplinary team environment
Preferred: Experience with international regulatory bodies such as the FDA, EMA or TGA
Preferred: Familiarity with quality management systems and risk management principles
What we can provide:
You will have the opportunity to work with an exceptional and highly engaged team while building and growing your career.
In addition, we offer:
Flexible working options.
Competitive annual salary & bonus package
Varied career experiences and personalised development support.
Wellbeing benefits.
Diversity and Inclusion initiatives and program.
Free parking onsite.
Volunteering & wellbeing leave.
Product allowance.
Apply now
If you are a detail-oriented regulatory professional passionate about ensuring the safety and efficacy of pharmaceutical and medical device products, we would like to hear from you. Please submit your CV, cover letter and contact details to join The Better Health Company today.