Description:
1 week ago Be among the first 25 applicants
Recruiting Regulatory Affairs & Quality Assurance Professionals across Australia & New ZealandAre you ready to lead and shape the future of Scientific Affairs in a growing, trusted pharmaceutical company?
A leading Australian-owned pharmaceutical company is seeking a dynamic and strategic Director of Scientific Affairs to propel the business into its next phase of growth and success. This is a unique opportunity to shape the future of scientific affairs, strengthen regulatory and compliance functions, and drive product excellence.
The company has built a strong foundation and is poised for continued growth. With an ambitious vision, they need a forward-thinking leader who can elevate the Scientific Affairs function—ensuring ongoing compliance, innovation, and market leadership.
As Director, you will provide strategic leadership across Regulatory Affairs, Pharmacovigilance, Medical Information, and Quality Assurance. You’ll drive business expansion, lead the development of robust scientific strategies, and strengthen internal and external partnerships, all while ensuring the highest standards of product quality and regulatory compliance.
Key Responsibilities:
- Lead and manage Scientific Affairs functions, including Regulatory, Pharmacovigilance, Medical Information, and Quality Assurance ensuring alignment with company objectives.
- Develop and execute regulatory strategies to ensure timely market access for new products and ongoing compliance for existing ones, including managing product registrations and change control processes.
- Oversee the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring compliance with relevant global standards (e.g., TGA, FDA).
- Provide strategic leadership to a high-performing team, driving their development and setting clear performance targets to meet the company’s business goals.
- Build and maintain relationships with regulatory bodies and other key stakeholders, ensuring smooth product approvals and compliance across multiple regions.
- Drive operational efficiency and continuous improvement within Scientific Affairs, optimizing processes across Regulatory, Pharmacovigilance, and Quality functions to support business growth.
About You:
- Proven leadership experience, with the ability to guide and develop cross-functional teams in Scientific Affairs, Regulatory, and Quality functions.
- Strong regulatory expertise, with a track record of executing successful market access strategies and ensuring compliance across the full product lifecycle.
- Exceptional problem-solving and analytical skills, with a knack for navigating complex regulatory, pharmacovigilance, and compliance challenges.
- Demonstrated ability to build, implement, and enhance Quality Management Systems (QMS).
Why Apply?
- Strategic leadership role with real influence across the business.
- Join a values-led Australian company with a strong foundation in healthcare.
- Opportunity to build out and shape a key scientific function within the business.
If you're driven to lead and build, now’s the time to take that next step. Apply today.
Contact Ben Byrne on 0421776703 or bbyrne@i-pharmconsulting.com
Seniority level- Director
- Full-time
- Science
- Pharmaceutical Manufacturing