Regulatory Affairs Manager

About Our Client

They 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 Description

Key Responsibilities:

1. 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.

• 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.

• 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.

• 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.

• 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.

• 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.