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Senior Regulatory Affairs Specialist

2 months ago

Upper Hutt, New Zealand MSD Full time

Senior Regulatory Affairs Specialist Animal Health

This is a unique opportunity to join a leading Animal Health business that values innovation, growth, and diversity. As a Senior Regulatory Affairs Specialist, you will play a key role in driving the development, importation, and registration of new products, while ensuring regulatory compliance across the entire product range.

  • Develop and implement regulatory strategies to support new product development and registration projects.
  • Provide regulatory support for research trials, label extensions, and new technologies across ANZ.
  • Collaborate with regulatory authorities to gain market access for new technologies.
  • Identify and communicate risks to approvals or timelines agreed as part of project planning.
  • Provide regulatory and technical advice to other parts of the organization to ensure compliance and strategy development.
  • Ensure all advertising, promotional, and educational materials comply with applicable laws and regulations.
  • Participate in quality control investigations and recall actions as required.

Requirements

  • Graduate or post-graduate degree in a relevant biological science.
  • Background in Animal Health Regulatory Affairs is strongly preferred.
  • Knowledge of relevant New Zealand Regulatory Systems (ACVM, Biosecurity, EPA).
  • Highly developed skills in negotiating, influencing, leadership, communication, and organizational skills.
  • Ability to analyze data, logical and analytical approach to problem solving.
  • Self-starter with initiative, works well with minimal supervision.
  • Ability to work under pressure to meet deadlines and make sound decisions.
  • Understanding of quality systems.

What We Offer

  • Autonomous work environment with support and encouragement from a trusted Global Animal Health organization.
  • Opportunities for upskilling and career development.
  • Collaborative team environment with likeminded individuals.

We are a company that values diversity, talent, and commitment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.