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Exciting Regulatory Affairs Manager

Sydney Permanent View Job Description
The Regulatory Manager will play a crucial role in ensuring compliance with all relevant regulations and standards governing healthcare products and services. The ideal candidate will possess strong regulatory expertise, excellent communication skills, and the ability to work collaboratively across departments to drive regulatory strategies and initiatives.The role requires on-site presence .
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  • Work with a leading Australian Pharmaceutical product and service provider
  • High Impact & High Visibility role

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.
  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

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.
Contact
Shruti Patro
Quote job ref
JN-062024-6452332
Phone number
+61 2 8221 8144

Job summary

Function
Healthcare
Specialisation
Healthcare
What is your industry?
Healthcare / Pharmaceutical
Location
Sydney
Job Type
Permanent
Consultant name
Shruti Patro
Consultant phone
+61 2 8221 8144
Job Reference
JN-062024-6452332

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know. PageGroup acknowledge and pay our respects to the Traditional Custodians of the land we operate on.