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:
1. Lead, manage, and develop a team of four professionals focused on quality assurance, regulatory affairs, and technical aspects of product development.
2. Ensure all products meet the required quality standards throughout the lifecycle, from development through to post-market surveillance.
3. Oversee the development, implementation, and continuous improvement of quality assurance systems, ensuring compliance with Good Manufacturing Practice (GMP) and other relevant standards.
4. Ensure compliance with local and international regulatory requirements, including TGA (Therapeutic Goods Administration) in Australia and other regulatory bodies in key international markets.
5. Act as the key point of contact for regulatory affairs, liaising with authorities as needed to resolve compliance matters.
6. Perform audits of local and international contract manufacturers to ensure adherence to GMP and quality standards.
7. Lead qualification of new contract manufacturers and suppliers, ensuring compliance with company quality and technical specifications.
8. Manage customer complaints, change control processes, and any adverse events reporting.
9. Ensure product specifications and manufacturing/testing procedures align with international standards and regulations for various markets.
Skills:
1. Extensive experience in senior quality assurance or regulatory affairs roles in pharmaceuticals, consumer healthcare.
2. Strong knowledge of GMP and regulatory frameworks, particularly in consumer healthcare and medical devices.
3. Experience with regulatory bodies like the TGA and working with local and international contract manufacturers.
4. Proven leadership skills, able to manage and mentor a team while working autonomously.
5. 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.
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