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Regulatory Affairs Specialist
4 weeks ago
Job Description
Regulatory Affairs Specialist
- Permanent Full-time Opportunity based in Sydney
- Join 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 these regions is highly regulated and competitive, making it essential for the company's success to navigate regulatory processes efficiently and effectively.
The Regulatory Affairs Specialist is part of the Regulatory Affairs Operations organization and reports to the Regulatory Affairs Operations Team Leader.
What You Will Do
- Regulatory Submissions: 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: Manage regulatory processes, including artwork changes, marketing material approval, regulatory reporting, and maintenance of permits and licenses, while adhering to internal policies and legislative requirements.
- Change Control Support: Provide regulatory input for change control processes across manufacturing and quality networks, contributing to decision-making and strategy development with regulatory and technical advice.
- Pharmacovigilance Support (if applicable): Maintain current pharmacovigilance training and assist in processing local pharmacovigilance cases in compliance with company and regulatory standards.
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 or pharmaceutical manufacturing industry is highly beneficial.
Familiarity with 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.
- Analytical skills with a logical approach to problem-solving.
- Experience working across diverse projects and stakeholders.
What You Can Expect
- Autonomous work environment supported by a trusted, leading Global Animal Health organization.
- Opportunities to upskill and develop in your role.
- Join a collaborative team of like-minded individuals.
We value diversity and are committed to an inclusive workplace. We encourage respectful challenge and collective problem-solving. We are an equal opportunity employer.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, does not accept unsolicited assistance from search firms without a valid written agreement. All CVs/resumes submitted without such an agreement will be deemed the company's property, and no fee will be paid unless a pre-existing agreement is in place. Please, no phone calls or emails.
Additional Details:
- Employee Status: Regular
- Relocation: Not specified
- VISA Sponsorship: Not specified
- Travel Requirements: Not specified
- Flexible Work Arrangements: Not applicable
- Shift: Not specified
- Valid Driving License: Not specified
- Hazardous Material(s): Not specified
- Job Posting End Date: 06/3/2025
