Job Description

Regulatory Affairs Specialist

Permanent Full-time Opportunity based in SydneyJoin a market leading, experienced and motivated team in a growing exciting market

The Regulatory Affairs Specialist plays a crucial role in ensuring internal and external regulatory compliance for the manufacture, importation, and supply of the entire animal health product range in Australia and New Zealand. The pharmaceutical industry in Australia and New Zealand is highly regulated and competitive, making it essential for the compashny's success to navigate regulatory processes efficiently and effectively.

The Regulatory Affairs Specialist sits within the Regulatory Affairs Operations organization and reports to Regulatory Affairs Operations Team Leader.

What You Will Do

Regulatory Submissions: The Regulatory Affairs Specialist is responsible for submitting applications to regulatory authorities (e.g., APVMA, ACVM, DAFF) to maintain registrations in compliance with product changes and regulatory requirements.Compliance Management: Taking ownership of regulatory processes is another key responsibility. This includes managing changes in artwork, approving marketing materials, ensuring regulatory reporting and maintenance of permits and licenses, and adhering to internal policies and legislative requirements.Change Control Support: The Specialist provides regulatory input for change control processes across manufacturing and quality network. This involves contributing to decision making and strategy development by offering regulatory and technical advice to other parts of the organization.Pharmacovigilance Support (if applicable): If the Specialist has pharmacovigilance responsibilities, they must maintain current pharmacovigilance training and assist in processing local pharmacovigilance cases in compliance with company and regulatory requirements.

What You Must have

Graduate or Post-Graduate degree in a relevant biological science field.Minimum 5 years of experience in a related industry.Experience in the animal health industry or pharmaceutical manufacturing is highly beneficial.
Familiarity with the Australian and New Zealand Regulatory Systems (e.g., APVMA, DAFF, ACVM).
Strong negotiation and influencing skills.Excellent communication (both written and verbal) and organizational skills.Ability to work collaboratively in a team setting.Ability to analyse data with a logical and analytical approach to problem-solving.Demonstrated ability to work across diverse projects and stakeholders.

What You Can Expect

Work autonomously whilst being supported, encouraged and being part of a trusted, leading Global Animal Health organisationExposure to upskill and develop in your roleJoin a collaborative team of likeminded individuals

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. 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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/3/2025

*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.

Requisition ID:R346819