MSD Senior Regulatory Affairs Specialist 

New Zealand, Wellington, Wellington 

383205356

Job Description

Senior Regulatory Affairs Specialist Animal Health

• Looking for a role within an Animal Health business renowned for innovation, growth and diversity?
• Are you seeking the opportunity to develop your career?
• Join a diverse workforce that values collaboration

You will drive the development, importation and registration of new products and help support internal and external regulatory compliance for the entire product range. Your success in the role will be the effective management of new product development and registration projects.

You will play a key role in supporting our success in a highly regulated and competitive environment in the Animal Health pharmaceutical sector in New Zealand.

What You Will Do

• Registration of new products. Review, compile and submit registration dossiers and data packages for agreed key projects, within timeframes agreed with manager and in accordance with government, industry and corporate requirements to maintain regulatory compliance and facilitate product supply.
• Provide regulatory support to conduct research trials for new products or label extensions for existing products.
• Support the development of the regulatory strategy for new technologies across ANZ. This will include liaising with regulatory authorities with the view of gaining market access for these new technologies.
• Identify and communicate risks to approvals or timelines agreed as part of project planning.
• Propose options to address any technical / regulatory concerns as applicable.
• Provide regulatory and technical advice as requested to other parts of the organization to ensure that correct and compliant information is used in decision making and strategy development.
• Ensure all advertising, promotional and educational/technical materials that are related to products marketed comply with applicable local laws and regulations and consistent with all corporate Animal Health’s policies and standards and reflects our Code of Conduct.
• Participate in PQC investigations and recall actions as required.

What You Must have

• Graduate or post-graduate degree in a relevant biological science.
• A 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 with excellent communication and organizational skills.
• Ability to analyse data. Logical and analytical approach to problem solving.
• Self-starter with initiative who works well with minimal supervision.
• Ability to work under pressure to meet deadlines and to make sound decisions on a day-to-day basis concerning regulatory affairs.
• Understanding of quality systems.

What You Can Expect

• Work autonomously whilst being supported, encouraged and being part of a trusted Global Animal Health organisation.
• Exposure to upskill and develop in your role.
• Joining acollaborativeteam of

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.