Regulatory Affairs Analyst

Functional Skills are essential skills that help individuals perform tasks effectively in everyday life, work, and education.

Regulatory Knowledge

Documentation and Technical Writing

Submission Management

Communication and Negotiation

Project Management

Risk Assessment and Mitigation

Data Analysis and Interpretation

Quality Assurance

Problem Solving

Computer Skills

Communication, teamwork, and critical thinking to ensure seamless project execution.

Technical Skills are specialized abilities and knowledge needed to perform specific tasks or functions.

Task

95%

Ensuring compliance with Indian regulatory requirements for pharmaceutical products.

90%

Preparing and submitting regulatory documents to CDSCO (Central Drugs Standard Control Organization).

85%

Maintaining up-to-date knowledge of changes in Indian regulations and guidelines.

80%

Liaising with regulatory agencies to address queries and resolve issues.

75%

Reviewing and approving labeling and packaging materials for regulatory compliance in India.

70%

Conducting gap analysis to identify areas of non-compliance with Indian regulations.

65%

Developing and implementing regulatory strategies for new product registrations in India.

60%

Managing post-approval regulatory activities, such as variations and renewals, in the Indian market.

Work Activities

Detailed Work Profile

Interests