Regulatory Affairs Specialist

2 days ago

Sydney, New South Wales, Australia Michael Page Full time
About Our Client

Michael Page is a leading recruitment agency with a strong presence in the pharmaceutical industry. Our client is a reputable company that specializes in providing market-ready, TGA registered & listed, over-the-counter and prescription products, as well as vitamins, mineral supplements, medical devices, and various other niche products.

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.
  2. 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.
  3. 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.
  4. 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 their operations and products.
  5. 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.
  6. 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.

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