Regional Head of Quality & Regulatory

A leading pharmaceutical company specialising in OTC healthcare products is seeking a Regional Head of Quality and Regulatory Affairs.

In this senior leadership role, you will have full autonomy over the quality and regulatory functions, with a primary focus on driving and enhancing quality assurance across the business.

The ideal candidate will have a well-rounded background in pharmaceuticals, particularly in OTC products, with experience in regulatory reporting, quality assurance (including working with third-party manufacturers), and pharmacovigilance.

Although part of a global group, the company operates independently and has the financial strength to make quick, decisive decisions without the red tape. The successful candidate will be hands-on in managing and developing a team of four, driving successful outcomes across the business.

The role will have a 60% focus on quality, 30% on regulatory, and 10% on technical matters. The company offers flexible working arrangements and on-site parking.

Duties include:

• Lead, manage, and develop a team of four professionals focused on quality assurance, regulatory affairs, and technical aspects of product development.
• Ensure all products meet the required quality standards throughout the lifecycle, from development through to post-market surveillance.
• Oversee the development, implementation, and continuous improvement of quality assurance systems, ensuring compliance with Good Manufacturing Practice (GMP) and other relevant standards.
• Ensure compliance with local and international regulatory requirements, including TGA (Therapeutic Goods Administration) in Australia and other regulatory bodies in key international markets.
• Act as the key point of contact for regulatory affairs, liaising with authorities as needed to resolve compliance matters.
• Perform audits of local and international contract manufacturers to ensure adherence to GMP and quality standards.
• Lead qualification of new contract manufacturers and suppliers, ensuring compliance with company quality and technical specifications.
• Manage customer complaints, change control processes, and any adverse events reporting.
• Ensure product specifications and manufacturing/testing procedures align with international standards and regulations for various markets.

Skills:

• Extensive experience in senior quality assurance or regulatory affairs roles in pharmaceuticals, consumer healthcare
• Strong knowledge of GMP and regulatory frameworks, particularly in consumer healthcare and medical devices.
• Experience with regulatory bodies like the TGA and working with local and international contract manufacturers.
• Proven leadership skills, able to manage and mentor a team while working autonomously.
• Excellent project management skills, managing multiple projects focused on quality, safety, and regulatory compliance.

Please note that international travel will be required to Europe and Singapore