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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
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
CMC Regulatory Strategy DevelopmentRegulatory Submissions PreparationRegulatory Affairs ExperienceKnowledge of Regulatory FrameworksStakeholder Management
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory DocumentationRegulatory ComplianceProduct Development ProgramsClinical Trial ApplicationsMarketing ApplicationsRisk AssessmentsChange ManagementAnalytical ThinkingProblem-SolvingProject Management
Soft Skills
Strong CommunicationOrganizational AbilitiesInfluencing SkillsCollaboration
Industry Keywords
BiotechnologyPharmaceutical IndustryBiological Medicinal ProductsGlobal Regulatory RequirementsManufacturingQualityProcess DevelopmentHealth Authority InteractionsInspection ReadinessContinuous Improvement
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
- Fluent in English
- Strong communication and stakeholder management skills
- 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: copies of relevant academic transcripts and/or diplomas in the original language, and letters of reference
Benefits
Comp & perks- CSL benefits and well-being support (details provided via CSL benefits information page)
- Inclusion and belonging initiatives
- Reasonable accommodation support for applicants with disabilities