Regulatory Affairs Specialist

7 days ago

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

Michael Page is a leading recruitment agency specializing in professional staffing solutions. With a strong presence in the pharmaceutical industry, we understand the importance of regulatory compliance in ensuring the success of our clients.

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.
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 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 Ideal Candidate
  • 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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