About Our ClientThey are a leading pharmaceutical product and service provider. They are proudly Australian-owned, with over 25 years of experience servicing the pharmaceutical industry and provide the most extensive range of market-ready, TGA registered & listed, over-the-counter and prescription products, as well as vitamins, mineral supplements, medical devices, and various other niche products for their clients.Known for delivering market-ready, TGA registered and listed OTC products for pharmaceutical companies, pharmacy chains and retailers.
Job DescriptionKey Responsibilities: * Regulatory Compliance:
- Monitor and interpret relevant regulations, guidelines, and standards applicable to healthcare products and services.
- Develop and implement regulatory strategies to ensure compliance with local, regional, and international regulatory requirements.
- Conduct regulatory assessments and gap analyses to identify areas for improvement and ensure ongoing compliance.
- Product Registration and Approvals:
- Manage the preparation and submission of regulatory applications for product registrations, licenses, and approvals.
- Liaise with regulatory authorities and agencies to facilitate timely approvals and resolve any regulatory issues or queries.
- Maintain regulatory documentation and records in accordance with regulatory requirements.
- Quality Assurance and Control:
- Collaborate with quality assurance and quality control teams to ensure adherence to regulatory requirements related to product quality, safety, and efficacy.
- Participate in internal and external audits to assess compliance with regulatory standards and identify corrective actions as needed.
- Regulatory Strategy and Planning:
- Develop and execute regulatory strategies aligned with business objectives and market requirements.
- Provide regulatory guidance and support to cross-functional teams involved in product development, manufacturing, and marketing.
- Stay abreast of emerging regulatory trends and developments to anticipate potential impact on Neo Health's operations and products.
- Risk Management:
- Assess regulatory risks associated with product development, manufacturing, and distribution activities.
- Implement risk mitigation strategies to address potential regulatory challenges and minimize compliance-related issues.
- Training and Education:
- Conduct training sessions and workshops to educate internal stakeholders on regulatory requirements, processes, and best practices.
- Foster a culture of regulatory compliance and awareness throughout the organization
The Successful Applicant- Minimum of 3 years of experience in Regulatory Affairs within the healthcare industry.
- In-depth knowledge of regulatory requirements and standards governing medical devices, pharmaceuticals, or other healthcare products.
- Proven track record of successful regulatory submissions and approvals.
- Strong analytical skills with the ability to interpret complex regulatory documents and requirements.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
- Detail-oriented with strong organizational and project management capabilities
- Must have dealt with TGA and have connections there
- Should understand Medsafe, UK MHRA, etc
What's on Offer- Opportunity to be part of a dynamic and innovative healthcare company at the forefront of industry advancements.
- Competitive compensation and benefits package.
- Collaborative and inclusive work environment that values diversity and creativity.
- Career growth and development opportunities.
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