Senior Quality and Regulatory Affairs Associate

Senior Quality and Regulatory Affairs Associate

Menarini Asia-Pacific Chatswood, New South Wales, Australia (On-site)

Welcome to Menarini Australia, where talent meets opportunity As you consider your next career move, we invite you to explore the exciting possibilities that await you here. At Menarini, we are dedicated to cultivating a dynamic and inclusive workplace culture where your unique skills and perspectives are valued.

About Us

A.Menarini, a subsidiary of the Italy-based Menarini Group, is a leading biopharmaceutical company focused on delivering differentiated healthcare consumer and ethical brands. Leveraging the extensive global infrastructure and go-to-market expertise of the Menarini Group, along with our unique insights of the Asia-Pacific markets, patients and physicians, we undertake biopharmaceutical brands from R&D, through to manufacturing, regulatory approvals, sales and marketing.

Senior Quality & Regulatory Opportunity

We are seeking a driven and experienced
Senior Quality and Regulatory Affairs Associate
to join our team. In this role you will have the autonomy to lead key projects and deliverables, ensuring the highest level of compliance is maintained for our new and existing registrations in Australia and New Zealand.

This senior role is integral to our operations, responsible for registering and maintaining a diverse portfolio of medicines, while also taking ownership for maintaining and improving our Pharmaceutical Quality System.

In this pivotal role, you will:

• Lead End-to-End Submissions:
  Take responsibility for assigned product registrations, major applications (including Category 1), and maintenance variations, managing the process from gap analysis through to a favourable outcome with minimal oversight.
• Drive the Pharmaceutical Quality System (PQS):
  Maintain the local PQS and monitor its compliance status, managing deviations, CAPAs, and supporting recall management.
• Manage Quality Operations:
  Manage all Product Quality Complaints, support the release of incoming stock, and lead both internal and external audits.
• Act as a Strategic Partner:
  Provide regulatory advice to internal stakeholders, represent the Regulatory Affairs department in cross-functional teams and meetings, and guide the development of junior staff as requested.
• Ensure Compliance and Improvement:
  Maintain all registration files, establish and maintain Quality Agreements with vendors, and identify areas for continuous business improvement within your area of responsibility.

Qualifications

• Tertiary qualification in
  Pharmacy, Life Science
  or a related field.
• A minimum of
  4 years' experience
  in a Quality Assurance and Regulatory Affairs role at an ANZ innovative pharmaceutical company
• Demonstrated experience in planning, preparing, and negotiating major submissions for new chemical and/or biological entities.
• End-to-end experience in all application types, including
  Category 1
  .
• Experience in OTC, complementary, device, and cosmetic areas is highly desirable.
• Prior
  auditing experience
  and knowledge of relevant GMP guidelines.

Skills and Attributes

• Strong
  analytical skills
  and attention to detail with the ability to devise pragmatic solutions.
• Exceptional persuasive written/verbal
  communication and presentation skills
  .
• Strong
  interpersonal skills
  with a demonstrated ability to work well with cross-functional teams and drive consensus.
• Intellectually curious
  with a proactive approach to researching regulatory issues.
• Demonstrated flexibility to adjust to changing needs and priorities within the organisation.

How to Apply

If you're a self-motivated professional with a passion for regulatory compliance and quality assurance in the healthcare sector, we want to hear from you. Apply now with your resume and cover letter outlining your relevant experience and why you'd be a great fit for this role.
Applications close 3 October, 2025.

Menarini Australia is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Applications are via LinkedIn.