The Aicila Group - International Recruitment & Consulting Specialists – Sydney NSW
Regulatory Affairs & Quality Manager (Australia)
Are you ready to be the regulatory champion for cutting-edge Pharmaceutical products across Australia & New Zealand? We are searching for a highly experienced and meticulous Regulatory Affairs & Quality Manager to lead our client's compliance efforts.
This critical leadership role drives product safety, quality, and market access by mastering both local and global requirements for pharmaceuticals.
This is a multi-faceted leadership role encompassing Regulatory Affairs, Quality Assurance, and Pharmacovigilance.
Key Responsibilities And Missions
The successful candidate will own compliance across three core areas:
Regulatory Affairs Leadership Strategic Submissions: Prepare and oversee all product registration submissions and variations across the territory.
Market Access: Expedite applications and negotiate approvals by expertly liaising with government regulatory authorities.
Compliance: Manage import permits, license applications, and product labeling to ensure full government compliance.
Quality & GMP Management QMS Oversight: Manage all Quality Assurance matters from Release for Sale to product destruction, ensuring adherence to GMP and all internal/external quality policies.
Cross-Functional Expertise: Provide essential regulatory and quality guidance to internal teams, including ensuring marketing materials comply with local requirements.
Pharmacovigilance (PV) System Implementation: Establish and maintain the local PV system, ensuring compliance with national and European legal requirements.
Safety & Risk: Manage the collection, assessment, and timely reporting of adverse events, and evaluate the benefit-risk profile of our medicinal products.
Audit Readiness: Lead participation in internal PV audits and national competent authority inspections.
Your Expertise (Required Experience) Minimum of 3 - 5 years' experience in a pharmaceutical quality system and GMP regulated environment.
Essential knowledge of regulatory requirements for Pharmaceutical products.
Relevant background in the pharmaceutical industry is essential.
A degree in life sciences (medicine, pharmacy, veterinary medicine, chemistry, or related field) is preferred, or comparable industry experience.
This is a high-impact position where your expertise directly ensures business compliance and product safety.
You will report directly to the ANZ Managing Director (and be part of the ANZ leadership team) while maintaining strong functional alignment with our Global Directors of Regulatory Affairs, Quality Assurance, and Pharmacovigilance.
Our client is committed to fostering an inclusive and diverse workplace where all individuals are respected and valued.
Join them and be part of a team that embraces diversity and works collaboratively to drive breakthrough innovation in their field.
Apply now and take the first step towards an exciting career journey
Please note only applicants who meet the above criteria will be contacted.
This role is only open to those who have the right to work permanently and
who have validated local experience in Australia.
No Visa or Sponsorship offered.
Fluent English language skills are expected.
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