About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

As a member of Abbott Nutrition (AN) Regulatory Affairs, this role has the overall responsibility for management of the New Zealand nutrition regulatory affairs manufacturing site support, strategy development and compilation of regulatory submissions. It also provides regulatory advice to support the business activities by maintaining a high level of engagement with all internal and external stakeholders.

What You'll Do:

• Provide leadership and strategic direction to the ANI Regulatory department and AN manufacturing sites in New Zealand.

• Manage regulatory submissions to obtain and maintain product approvals in accordance with agreed business priorities using best-in-class regulatory documentation for all types of submissions including new/re-registrations, reimbursement, novel ingredient applications, additive petitions, claims petitions, deficiency responses and other submissions required by local agencies.

• Develop regulatory strategies for all product registration submissions

• Generate and/or obtain registration documentation (COFS, Health Certifications, RMP approvals, etc.) to support product/site submissions for export markets.

• Conduct formula assessments for products produced at NZ manufacturing sites to identify OMAR requirements and potential NZ Export exemption submissions to MPI.

• Oversee all post-approval lifecycle management activities like change control, AN system updates, emerging regulation impact to existing portfolio, & license maintenance; and maintain documentation on decision/actions taken

• Interpret, analyse, and identify regulatory requirements for new projects. Provide regulatory advice to cross functional stakeholders (quality assurance, supply chain, product development, regulatory affairs and other functions as required.

• Negotiate with regulatory authorities to facilitate review and approval of all product submissions

• Monitor changes in the external environment (regulatory changes) and ensure impact of any changes is assessed, potential solutions formulated (like scenario planning, position papers etc.) and communicated to relevant local and regional functions through established AN policies & processes

• Provide timely input into Abbott Nutrition positions on emerging issues/regulations and implement plans to respond, influence or mitigate potential losses, and identify opportunities in legislative/regulatory area.

Requirements:

• Bachelors Degree in Science Degree or equivalent – preferred area of focus in science (nutrition, dietetics, biology, chemistry, pharmacy, pharmacology, microbiology, or medical technology)

• Minimum 8 years of relevant Regulatory experience in food, dietary supplement, pharmaceutical or Fast-Moving Consumer Goods (FMCG) industry, with a minimum of 2 years in leadership role preferred

• Strong knowledge of New Zealand regulatory frameworks

• Demonstrated experience in working collaboratively with Regulatory bodies like MPI, FSANZ, MedSafe, and other statutory authorities

• Experience with quality systems, food safety programs and export compliance preferred

Location:

This position is based in Auckland > Richard Pearse Drive.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.