Regulatory Manager

Job Description

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.
• O...