Hard Skills

• Regulatory submissions
• Regulatory strategy development
• Regulatory risk assessment
• Labeling review and approval
• Regulatory documentation management
• Dossier preparation (eCTD, CTD)
• Product registration
• Change control management
• Regulatory impact assessment
• Compliance auditing
• Regulatory intelligence
• Standard operating procedures (SOPs)
• Quality system compliance
• Clinical trial applications support
• Risk–benefit analysis

Technical Proficiencies

• FDA regulations (21 CFR)
• EMA guidelines
• ICH guidelines
• ISO standards (e.g., ISO 13485)
• Good Manufacturing Practices (GMP)
• Good Clinical Practices (GCP)
• Good Laboratory Practices (GLP)
• Electronic Common Technical Document (eCTD) publishing
• Regulatory information management systems (RIMS)
• Document management systems (DMS)
• Medical device regulations (MDR, IVDR)
• Pharmaceutical regulations
• US IND/NDA/BLA submissions
• EU MAA submissions
• Post-market surveillance requirements

Soft Skills

• Cross-functional collaboration
• Stakeholder communication
• Attention to detail
• Analytical thinking
• Regulatory problem-solving
• Time management
• Project coordination
• Influencing and negotiation
• Adaptability to changing regulations
• Strategic thinking

Industry Knowledge

• Drug development lifecycle
• Medical device lifecycle
• Lifecycle management
• Post-approval changes
• Pharmacovigilance basics
• Clinical development process
• Health authority expectations
• Global regulatory pathways
• Product labeling requirements
• Market authorization procedures

Industry Certifications & Credentials

• RAC (Regulatory Affairs Certification)
• RAPS membership
• PMP or project management training
• GxP training (GMP, GCP, GLP)
• Quality management training
• Compliance and ethics training

Action Verbs

• Authored
• Compiled
• Submitted
• Reviewed
• Interpreted
• Ensured compliance
• Liaised
• Coordinated
• Advised
• Implemented
• Monitored
• Maintained
• Streamlined
• Negotiated
• Updated