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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 regulatory strategies for pharmaceutical products, ensuring compliance with regional requirements and effective communication with Health Authorities. Possesses strong analytical skills to assess regulatory impacts and manage risks while fostering cross-functional collaboration.
Highest-signal resume keywords
Regulatory Strategy DevelopmentRegulatory Submission DocumentationGMP UnderstandingGCP UnderstandingCross-Functional Collaboration
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 ExperienceBiological Science DegreeMedical Science DegreePharmacy DegreeDrug Regulatory Affairs QualificationScientific Principles UnderstandingTechnical Requirements UnderstandingRegulatory Risk ManagementProcess ImprovementCompliance
Soft Skills
Relationship BuildingStrategic OversightCollaborationCommunication
Industry Keywords
Health AuthorityInternational LegislationPharmaceutical IndustryOperational ExcellenceEmerging Regulatory Risks
About the role
Key responsibilities & impact- Serve as the regional regulatory strategist for assigned product portfolios and countries across designated regions or sub-regions
- Develop and implement regulatory strategies aligned with regional requirements and efficient approval pathways
- Contribute to RST activities and Global Regulatory Strategy development
- Plan and prepare projects or responses for complex scientific questions requiring product expertise and cross-functional collaboration
- Lead strategic oversight of regulatory activities to drive optimal Health Authority outcomes
- Anticipate and manage emerging regulatory risks
- Oversee high-quality regulatory submission documentation and responses to Health Authority questions
- Collaborate with Local Regulatory Representatives, Regulatory Partner Representatives, and internal stakeholders
- Build relationships with regional Health Authorities and support positive outcomes for CSL
- Monitor international legislation and guidelines relevant to CSL products and initiatives
- Assess local or regional regulatory impacts and identify potential regulatory risks
- Contribute to continuous process improvements, compliance, and operational excellence
Requirements
What you’ll need- A degree in Biological or Medical Science or Pharmacy
- Post-graduate qualification preferred
- Degree in Drug Regulatory Affairs advantageous
- At least 5 years of regulatory experience within international markets
- Additional pharmaceutical/industry experience
- English mandatory
- Additional language is an asset, such as Arabic, French, Spanish, or Russian
- Understanding of scientific principles and technical requirements relevant to pharmaceutical product development
- Understanding of GMP and GCP principles
- Applications must include a motivation letter and CV
Benefits
Comp & perks- Benefits information available via CSL’s “How CSL Supports Your Well-being” resource
- Inclusion and Belonging culture
- Reasonable accommodation for applicants with disabilities