Regulatory Affairs Manager | Animal Health
vor 8 Stunden
Work for a global Animal Health Pharmaceutical company Location: Brisbane (preferred), Sydney, or Melbourne.
Work Arrangement: Part-time (25-30 hours/week) with potential for full-time Position Summary A global Animal Health Pharmaceutical company, is seeking a dedicated Regulatory Affairs Manager to join their dynamic team.
This hybrid role will involve managing regulatory affairs, pharmacovigilance, and quality assurance for our Australian and New Zealand operations.
The ideal candidate will be a passionate veterinarian with a strong understanding of regulatory compliance and a commitment to ensuring the safety and efficacy of our products.
Key Responsibilities: Regulatory Affairs: Oversee and prepare submissions for product registrations and variations in Australia and New Zealand.
Manage regulatory submissions in accordance with global and local affiliate plans.
Liaise with regulatory authorities and participate in industry activities to influence regulatory policies.
Ensure compliance with import permits and license applications.
Maintain global product records and manage the regulatory/QA budget.
Pharmacovigilance: Implement and maintain the local Pharmacovigilance system.
Collect, record, assess, and report adverse events.
Conduct surveillance and evaluation of product safety.
Manage deviations and CAPAs.
Prepare for and participate in regulatory inspections.
Quality Assurance: Manage all quality assurance matters, including product release and destruction.
Marketing Compliance: Liaise with marketing to ensure compliance of marketing materials.
Manage product labels for regulatory compliance.
Qualifications: Veterinary degree or equivalent science qualification.
Ideally 10 years of experience in the animal health industry.
Strong understanding of regulatory requirements in Australia and New Zealand.
Experience in Regulatory Affairs and understand pharmacovigilance and quality assurance.
Excellent communication and interpersonal skills.
Proficiency in Microsoft Office Suite.
Benefits: Competitive salary of $130,000 - $150,000 base plus superannuation.
Hybrid work arrangement.
Opportunity for professional development and growth.
Join a global leader in animal health.
Location: Brisbane is preferred, but Sydney and Melbourne will also be considered for the right candidate.
Sound good?
Need more info?
Apply today to ****** or call Conie direct on 0483 988 164 for a confidential discussion.
We have other live vacancies too.
If this role isn't quite right for you, call us or apply to find out more.
NB: All candidates who meet our client's shortlist requirements will be contacted.
Know someone who would also thrive in the opportunities we have available?
Please forward along to them.
Thanks
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