Regulatory Affairs Career

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

Regulatory Strategy Development

Dossier Preparation and Submission

Liaison with Regulatory Authorities

Knowledge of Indian Regulatory Framework

Pharmacovigilance

Quality Assurance and Compliance

Technical Writing and Documentation

Project Management

Analytical and Problem-Solving Skills

Understanding of Intellectual Property

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.

92%

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

90%

Managing drug registration processes and renewals for the Indian market.

88%

Monitoring changes in Indian regulations and advising on their impact.

85%

Liaising with regulatory authorities to address queries and resolve issues.

82%

Conducting regulatory gap analysis and developing mitigation strategies.

80%

Reviewing and approving product labeling and packaging to ensure compliance.

78%

Supporting regulatory inspections and audits of manufacturing facilities.

75%

Maintaining regulatory files and databases for easy retrieval and tracking.

72%

Providing regulatory training to internal teams on Indian regulations.

70%

Assessing the regulatory implications of new product development projects.

68%

Managing post-market surveillance activities and reporting adverse events.

Work Activities

Detailed Work Profile

Interests