Regulatory Affairs Consultant - FSP (CMC)

Job Details

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:

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

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