Regulatory Affairs Consultant - FSP (CMC)

This role requires 3 days a week at the client office in Melbourne.

Key Responsibilities:

Strategic Leadership:

• Provide strategic direction and oversight for CMC aspects of late-stage and marketed products
• Deliver strategic input on critical cross-project topics, ensuring alignment with overall business objectives
• Develop comprehensive CMC strategies to support product development, registration, and lifecycle management

Regulatory Strategy and Submissions:

• Develop and oversee CMC strategies for complex regulatory submissions, including:
  • Investigational New Drug (IND) applications
  • Investigational Medicinal Product Dossiers (IMPDs)
  • Biologics License Applications (BLAs)
  • Marketing Authorization Applications (MAAs)
  • Post-approval variations/supplements
  • Responses to health authority questions
• Author and review high-level regulatory submissions
• Ensure all submissions conform to relevant health authority guidelines and regulations
• Lead submission preparation meetings and coordinate cross-functional input

Health Authority Interactions:

• Lead regulatory CMC discussions and interactions with Health Authorities
• Represent the company in high-level meetings with regulatory agencies
• Develop strategies for addressing complex regulatory questions and issues
• Build and maintain positive relationships with key regulatory stakeholders

Regulatory Assessment and Change Management:

• Oversee regulatory assessments of manufacturing changes
• Establish data requirements and strategies for regulatory submissions related to manufacturing changes
• Provide expert guidance on CMC-related regulatory implications of proposed changes

Project Management and Leadership:

• Represent Regulatory CMC at high-level project team meetings and governance committees
• Lead critical submission preparation meetings and regulatory strategy discussions
• Address complex reviewer comments and manage sensitive regulatory correspondence
• Provide regular updates to senior management on project status, risks, and key milestones
• Mentor and develop team members in Regulatory CMC practices and strategic thinking

Cross-functional Collaboration:

• Work closely with senior leaders across various departments, including R&D, Manufacturing, Quality Assurance, and Clinical Development
• Facilitate effective communication between internal teams, external partners, and regulatory authorities
• Provide expert CMC regulatory guidance to support critical business decisions and product lifecycle management

Regulatory Intelligence and Innovation:

• Stay at the forefront of evolving CMC regulations, guidelines, and industry best practices
• Drive the development and implementation of innovative CMC regulatory strategies
• Participate in and potentially lead relevant industry groups and regulatory authority initiatives

Qualifications:

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field (Ph.D. preferred)
• Minimum of 15+ years of experience in Regulatory Affairs, with a strong focus on CMC for late-stage and marketed products
• Extensive knowledge of global CMC regulatory requirements, submission processes, and health authority expectations
• Proven track record of successful regulatory submissions and positive health authority interactions
• Deep understanding of pharmaceutical development, manufacturing processes, and quality systems
• Experience with both small molecules and biologics is highly desirable
• Excellent project management skills with the ability to oversee multiple complex projects simultaneously
• Strong analytical and problem-solving skills
• Outstanding written and verbal communication skills
• Demonstrated ability to influence and lead at senior levels within an organization

Desired Qualities:

• Visionary leader with the ability to anticipate and navigate complex regulatory challenges
• Strategic thinker with a talent for innovative problem-solving and risk management
• Strong leadership skills with the ability to influence cross-functional teams and senior management
• Proactive and self-motivated with a commitment to regulatory excellence
• Adaptable to changing priorities and evolving regulatory landscapes
• Excellent interpersonal skills with the ability to build strong relationships with internal and external stakeholders
• Detail-oriented with a focus on quality and accuracy, while maintaining a big-picture perspective
• Ability to thrive in a fast-paced environment and manage competing priorities