Regulatory Affairs Manager
vor 2 Wochen
Known for delivering market-ready, TGA registered and listed OTC products for pharmaceutical companies, pharmacy chains and retailers.Job Description
Key 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 ApplicantMinimum 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 capabilitiesMust have dealt with TGA and have connections thereShould understand Medsafe, UK MHRA, etc
What's on OfferOpportunity 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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