Regulatory Manager

Description

• 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.

Qualifications

• 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