Regulatory Affairs Manager CMC

7 days ago

Sydney, New South Wales, Australia Artixio Consulting Pvt Ltd Full time

Role Overview

We are seeking an experienced Regulatory CMC Manager to lead and support Chemistry, Manufacturing and Controls (CMC) regulatory activities. The role involves client engagement, project management, regulatory document review, and preparation of submissions with a specific focus on TGA (Australia) and Medsafe (New Zealand) requirements.

You will serve as the bridge between global regulatory CMC teams, internal stakeholders, and regulatory authorities.

Key ResponsibilitiesProject & Client Management

  • Act as primary point of contact for assigned CMC projects, ensuring alignment with client expectations and regulatory timelines.
  • Liaise directly with client regulatory teams and internal stakeholders to manage priorities and communicate project updates.
  • Review incoming regulatory requests and triage to appropriate team members for execution.

Regulatory CMC Activities

  • Conduct CMC assessments and manage regulatory follow-ups related to submissions with TGA and Medsafe.
  • Lead the preparation and review of variation packages, ensuring quality and compliance before submission.
  • Draft and submit regulatory submissions including:
  • New applications
  • Variations
  • Responses to RFIs (Requests for Information)
  • Oversee post-approval regulatory activities, including notifications, condition fulfillment, and license maintenance.

Internal Collaboration & Support

Support the internal team by:

  • Providing background and context on products or manufacturing changes
  • Conducting training sessions or knowledge sharing
  • Performing secondary reviews of submission documents
  • Acting as signatory for regulatory submissions, where required

Qualifications & Skills

  • Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or related field
  • Minimum 5 years of experience in Regulatory Affairs with strong CMC exposure
  • In-depth understanding of TGA and Medsafe regulatory frameworks, especially variation processes
  • Proven experience in preparing Module 3 / CMC documentation
  • Strong attention to detail and ability to manage multiple projects simultaneously
  • Excellent communication, documentation, and project management skills
  • Ability to work effectively in a client-facing and cross-functional team environment

Job Types: Full-time, Contract

Contract length: 12 months

Pay: $93,155.95 – $160,000.25 per year

Benefits:

  • Work from home

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