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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in CMC regulatory activities, including the preparation and review of regulatory submissions and documentation for clinical trial applications and product registrations. Possesses strong analytical and project management skills to drive global CMC strategies and ensure compliance with regulatory guidelines.
Highest-signal resume keywords
CMC Regulatory ActivitiesRegulatory SubmissionsBiotech Industry ExperienceProject ManagementCommunication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Framework KnowledgeImpact AssessmentsDossier PreparationGMP Inspection SupportTechnical DocumentationRisk AssessmentGap AnalysisBiological Medicinal Products KnowledgeCMC DocumentationRegulatory Liaison
Soft Skills
Problem SolvingTeam CollaborationAttention to DetailOrganizational SkillsFlexibility
Tools & Technologies
Microsoft Office
Industry Keywords
BiotechPharmaceuticalRegulatory AffairsClinical TrialsProduct Lifecycle ManagementHealth Authority InteractionsCross-Cultural Work EnvironmentNatural Sciences DegreeCTAsINDs
About the role
Key responsibilities & impact- Lead strategic and operational CMC regulatory activities across product development, clinical submissions, registrations, and lifecycle management
- Drive global CMC strategies for clinical trial applications, new product licenses, and post-approval changes
- Assess CMC, facility/equipment, and plasma-related changes and manage regulatory submissions with regional teams
- Serve as primary regulatory liaison with technical experts and support GMP inspections and inspection readiness
- Interpret regulatory guidelines and requirements, prepare impact assessments, and contribute to process improvements
- Provide technical guidance to the organization
- Maintain relevant parts of regulatory dossiers
- Prepare, revise, and review Module 2.3, Module 3, facility and equipment information, and related documents for registrations and lifecycle submissions
- Author dossier narratives and other regulatory CMC documentation
- Provide responses to CMC-related Health Authority questions
- Compile and review CMC information for CTAs, INDs, Scientific Advice Meetings, Briefing Books, and IBs
- Support regulatory assessments and execution of CMC changes
- Prepare and review CMC information for tenders, PSURs, DSURs, CCDS/product information, and promotional materials
- Contribute to annual product quality reviews and risk assessments
- Participate in Regulatory Affairs Strategy Teams and relevant CMC Regulatory Sub-Teams
- Represent Global Regulatory Affairs in CMC project teams
- Develop and implement global CMC regulatory strategies
- Interface with technical expert departments for project planning, technical documentation, and CMC regulatory questions
- Evaluate technical and scientific CMC information, perform gap analyses, and propose risk-remediation strategies
- Support scheduling and prioritization of CMC-related submissions
Requirements
What you’ll need- University degree in natural sciences (BS/BA/MS or equivalent)
- Minimum of 3 years’ experience in the biotech or pharmaceutical industry, with at least 1 year in Regulatory Affairs
- Sound knowledge in natural sciences with a focus on biological medicinal products
- Basic knowledge of the regulatory framework in at least one key region (US, EU, Japan, CH, Australia)
- Excellent communication, project management, planning, problem solving and presentation skills
- Strong team player with ability to develop constructive and effective relationships with peers and management
- Strong organizational and follow-up skills and attention to detail
- Ability to work with minimal supervision based on sound technical and analytical judgment
- Flexibility to work in a global cross-cultural work environment
- Microsoft Office skills
- Fluent in English and local language
- Application must include a motivation letter, CV, letters of references, and relevant transcripts and/or diplomas in the original language as applicable
Benefits
Comp & perks- Employer-provided CSL benefits; details provided via the CSL benefits page
- Inclusion and Belonging culture
- Reasonable accommodation support for applicants with disabilities