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JobsAbbott

Regulatory Manager

Abbott

Regulatory Manager

Abbott

New Zealand > Waikato: Pokeno Plant

·

On-site

·

Full-time

·

1w ago

     

JOB DESCRIPTION:

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

Abbott has entered into an agreement to purchase Synlait’s North Island assets in New Zealand, including the Pōkeno manufacturing facility. Acquiring this facility supports Abbott’s anticipated growth in the Pacific Asia region across our adult and pediatric nutrition products. The pending close of the agreement is April 1, 2026.

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 Waikato District > Pokeno.

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.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

AN Abbott Nutrition

        

LOCATION:

New Zealand > Waikato: Pokeno Plant

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     

     

     

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About Abbott

Abbott

Abbott

Public

Abbott is a global healthcare company that develops medical devices, diagnostics, branded generic medicines, and nutrition products.

10,001+

Employees

Abbott Park

Headquarters

Reviews

3.4

10 reviews

Work Life Balance

2.5

Compensation

4.0

Culture

2.8

Career

3.2

Management

2.5

45%

Recommend to a Friend

Pros

Good benefits and compensation

Supportive management/teams

Good company reputation and mission

Cons

Poor management and communication

Stressful work environment

Limited career advancement/favoritism

Salary Ranges

1,330 data points

Mid/L4

Senior/L5

Intern

Mid/L4 · Project Manager

215 reports

$136,922

total / year

Base

$117,670

Stock

-

Bonus

$11,503

$94,554

$201,278

Interview Experience

3 interviews

Difficulty

2.7

/ 5

Duration

14-28 weeks

Offer Rate

67%

Experience

Positive 67%

Neutral 33%

Negative 0%

Interview Process

1

Application Review

2

Recruiter Screen

3

Phone Screen

4

Hiring Manager Interview

5

In-person/Final Interview

6

Offer

Common Questions

Technical Knowledge

Behavioral/STAR

Past Experience

Culture Fit