Regulatory And Scientific Affairs Manager

Who are we?

Located in Eastern Creek, Caruso’s Natural Health is an innovative growing company with the vision of becoming a “Business of excellence that helps people all over the world lead healthier and happier lives”. With the story and passion of our founder Frank Caruso as the foundation of everything that we do, we are looking for a Regulatory and Scientific Affairs Manager to join our company on a full-time basis. 

About the role…

The primary role of the Regulatory and Scientific Affairs Manager is to ensure that Caruso’s Natural Health complies with all regulatory requirements for export and TGA listed products, safeguarding that products, services and processes comply with relevant regulations and manage interactions with regulatory bodies. You will provide Regulatory, Scientific and Technical Advice on the designed and manufactured products and play a pivotal role in bringing unique and innovative products to life.

What you’ll do….

Managing Regulatory Compliance and Communication

• Ensure the design, implementation, and continuous improvement of a Regulatory and naturopathic governance model that ensures our people define, make, report, and measure confident evidence based decisions that fulfil Caruso’s Natural Health strategic purpose in a safe secure and sustainable way 
• Prepare correspondence and provide advice on interpretation and application of regulatory legislation, legal changes and to ensure that all registrations remain compliant 
• Work closely with all departments and third party stakeholders to ensure effective regulatory submissions and provide advice and assurance regarding maintenance of plans and arrangements 
• Maintaining organizational compliance with legislative and regulatory obligations, including ownership of the ongoing stability requirements of the business, within the boundaries of TGA, GMP and PICs Code
• Maintain an efficient, effective and transparent records management system for all contracts, emails, versions and submission, capturing all records and management in a compliant manner and leveraging technology 
• Drive and support key strategic regulatory objectives, leading the way in all aspects of regulatory affairs, as an enabler to commercial success, always keeping within legal and ethical frameworks as they apply to our business practices

Research and Evidence Building

• Take a proactive forward thinking approach to providing innovative market fresh solutions to Natural Health that are also evidence based and research supported
• Provide accurate, clear advice and information on regulatory matters to internal and external stakeholders 

Products and Marketing Compliance

• Overseeing the maintenance of regulatory compliance of all products including finalization of product specifications, packaging, promotional material and all marketing content
• Support all aspects of product development and review including research, product development, claims and evidence substantiations, formulating, costings and budget to build a "Regulatory Dossier" for each product 
• Bringing products to market within the regulatory framework including AU and export market requirements and guidelines of TGAC & Medsafe

Leadership and Managing Your Team 

• Inspire your team, ensuring team members understand their roles, responsibilities and KPI’S and that every team member has a Performance Development Plan
• Contribute to a positive and supportive organizational culture, demonstrating a high level of integrity, respect and commitment, while promoting enjoyment, teamwork and innovation

Stakeholder Management

• Develop and maintain effective working relationships with internal and external stakeholders by representing Caruso’s Natural Health in a confidential and professional manner 
• Educate stakeholders on the Regulatory and naturopathic procedures, policy requirements and  guidelines 

What’s on offer?

• Collaborative team culture 
• Competitive remuneration package on offer 
• Head office Based in Eastern Creek, Secure on-site parking 
• Close to M4 M7 
• Great employee benefits and on-site facilities 

To be successful in this role, you need to: 

• 5+ years of demonstrated experience in a similar or equivalent role within a like business is essential together with a Degree in a relevant field of Science, Law or other discipline
• Proven success managing the Regulatory, Scientific Affairs and Naturopathic department and personnel is required together with a proven track record of successful regulatory submissions and approvals and experience dealing with the TGA
• Experience drafting policies and regulatory correspondence, critical analysis, procedure reviews and implementation
• Display an in-depth knowledge of regulatory requirements and standards of healthcare products within FMCG

If you believe you are the right fit for this role, please provide a cover letter outlining your suitability, demonstrating your experience and tell us your story. We look forward to hearing from you. 

Please email *********@carusoshealth.com.au or for more information on our company and products, please see our website: www.carusosnaturalhealth.com.au