Regulatory compliance and pharmaceutical regulations (DCGI, Schedule M, Schedule Y)

Regulatory documentation and dossier preparation

Knowledge of GMP (Good Manufacturing Practices) and quality standards

Regulatory submission processes and approval workflows

Compliance auditing and inspection management

Regulatory database and documentation systems

Risk assessment and mitigation strategies

Government relations and stakeholder management

Strong communication and presentation abilities

Stakeholder management and relationship building

Problem-solving and analytical thinking

Attention to detail and accuracy

Leadership and team coordination

Negotiation skills

Time management and prioritization

Adaptability to regulatory changes

Professional integrity and ethical conduct