Regulatory Manager

About Abbott

Abbott is a worldwide healthcare organization known for developing scientific advances that help improve health outcomes. The company continues to look ahead and adapt to shifts in medical science and technology.

Why Join Abbott

At Abbott, you can contribute to meaningful work while continuing to develop professionally and personally. The company supports career growth, learning, family wellbeing, authenticity at work, and a balanced life.

• Opportunities for career growth within an international organization.
• A workplace recognized across many countries for being a great place to work and for its strong reputation globally.
• Known for supporting diversity, working mothers, women leaders, and scientists.

Role Overview

This position sits within Abbott Nutrition Regulatory Affairs and is accountable for New Zealand nutrition regulatory support at manufacturing sites, regulatory strategy development, and preparation of regulatory submissions. The role also involves providing regulatory guidance to support business operations while working closely with internal and external stakeholders.

Key Duties

• Lead and guide the ANI Regulatory team and Abbott Nutrition manufacturing sites in New Zealand.
• Oversee regulatory filings needed to secure and maintain product approvals, using strong documentation standards for submissions such as new registrations, re-registrations, reimbursement matters, novel ingredient applications, additive petitions, claims-related petitions, deficiency responses, and other filings required by local authorities.
• Shape regulatory strategies for product registration activities.
• Prepare or source registration documents such as COFS, health certifications, RMP approvals, and similar materials for export market submissions.
• Review product formulas made at New Zealand sites to determine OMAR obligations and possible NZ export exemption submissions to MPI.
• Manage post-approval work, including change control, system updates, review of emerging regulation impacts on the current portfolio, license upkeep, and documentation of decisions and actions taken.
• Assess regulatory requirements for new initiatives and provide guidance to teams across quality assurance, supply chain, product development, regulatory affairs, and other relevant functions.
• Engage with regulatory authorities to help secure timely review and approval of submissions.
• Track regulatory developments, evaluate their possible impact, build response options such as scenario planning and position papers, and communicate findings through Abbott Nutrition policies and processes.
• Contribute timely input into Abbott Nutrition’s stance on new issues and regulations, then help implement plans to respond to, influence, or reduce potential risks while identifying regulatory opportunities.

Requirements

• A bachelor’s degree in science, or an equivalent qualification, preferably in a science-related discipline such as nutrition, dietetics, biology, chemistry, pharmacy, pharmacology, microbiology, or medical technology.
• At least 8 years of relevant regulatory experience in food, dietary supplements, pharmaceuticals, or FMCG, with preference for 2 or more years in a leadership position.
• Strong familiarity with New Zealand regulatory systems.
• Proven experience working with agencies such as MPI, FSANZ, MedSafe, and other statutory bodies.
• Background in quality systems, food safety programs, and export compliance is preferred.

Location

The role is based in Auckland at Richard Pearse Drive.

Equal Opportunity

Abbott is committed to inclusive hiring and is an equal opportunity employer.