GRA CMC Scientist

CSL

. Develop and implement global CMC regulatory strategies for product development programs, clinical trial applications, marketing applications, and post-approval changes .

Posted 10/2/2026full-timeMelbourne • AustraliaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and implementing global CMC regulatory strategies, ensuring compliance throughout the product lifecycle, and providing strategic guidance within cross-functional teams. Proficient in regulatory submissions and understanding of global regulatory frameworks for biological medicinal products.

Highest-signal resume keywords

Regulatory Affairs ExperienceCMC Regulatory Strategy DevelopmentRegulatory Submissions PreparationKnowledge of Regulatory FrameworksStakeholder Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Documentation PreparationRegulatory ComplianceProduct Quality ReviewRisk AssessmentChange ManagementAnalytical ThinkingProblem-SolvingProject ManagementManufacturing Process DevelopmentBiological Medicinal Products Knowledge

Soft Skills

Strong CommunicationOrganizational AbilitiesInfluencing SkillsCollaboration Across Teams

Industry Keywords

Biotech IndustryPharmaceutical IndustryGlobal Regulatory RequirementsClinical Trial ApplicationsMarketing ApplicationsPost-Approval ChangesInspection ReadinessCross-Functional TeamsStakeholder EngagementRegulatory Impact Assessment

About the role

Key responsibilities & impact

Develop and implement global CMC regulatory strategies for product development programs, clinical trial applications, marketing applications, and post-approval changes
Coordinate the preparation, review, and maintenance of CMC regulatory documentation for global submissions
Ensure regulatory dossiers remain accurate, current, and compliant throughout the product lifecycle
Partner with cross-functional technical teams to assess manufacturing, facility, equipment, and process changes and determine regulatory impact
Prepare and review regulatory content for marketing applications, clinical trial applications, lifecycle variations, and responses to health authority questions
Provide regulatory input into development projects, product quality reviews, risk assessments, and change management activities
Interpret evolving global regulatory requirements and assess their impact on products and development programs
Support inspection readiness activities and contribute to continuous improvement of regulatory processes
Act as a key regulatory partner within cross-functional project teams, providing CMC expertise and strategic guidance
Report to the relevant Associate Director, Regulatory Affairs

Requirements

What you’ll need

Degree in a scientific discipline such as Biotechnology, Biological Sciences, Chemistry, Pharmacy, or a related field
Minimum of 3 years’ experience in the biotech or pharmaceutical industry
At least 1 year in Regulatory Affairs
Experience within Regulatory Affairs, CMC, manufacturing, quality, process development, or a related function
Understanding of regulatory requirements associated with biological medicinal products
Knowledge of regulatory frameworks within at least one key region (US, EU, Japan, CH, Australia)
Experience preparing or contributing to regulatory submissions
Strong communication and stakeholder management skills
Fluent in English
Excellent planning, project management, and organisational abilities
Analytical thinking and strong problem-solving capability
Ability to influence and collaborate across diverse, global teams
Work rights for the preferred location
Swiss candidates must provide relevant academic transcripts and/or diplomas in the original language as applicable and letters of reference

Benefits

Comp & perks

Benefits information available via CSL's “How CSL Supports Your Well-being” resource
Equal Opportunity Employer
Reasonable accommodation available for applicants with disabilities