Regulatory Affairs Career

Functional Skills

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

Soft Skills

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

Communication Skills

Attention to Detail

Critical Thinking

Problem-Solving

Negotiation Skills

Time Management

Adaptability

Teamwork and Collaboration

Ethical Conduct

Technical Proficiency

Technical Skills

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

Regulatory Submissions

Knowledge of Indian Regulatory Environment

Clinical Trial Regulations

Pharmacovigilance

GMP (Good Manufacturing Practices)

Medical Writing

Quality Assurance

Project Management

Data Analysis

Communication and Negotiation

Duties and Responsiblities

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

95%

Developing and implementing regulatory strategies for new and existing pharmaceutical products in the Indian market.

92%

Preparing and compiling regulatory dossiers for submission to Indian regulatory authorities like CDSCO.

90%

Interacting with regulatory agencies to address queries, provide additional information, and expedite the approval process.

88%

Monitoring and ensuring compliance with current Indian regulations and guidelines for pharmaceutical products.

85%

Reviewing and approving labeling and packaging materials to ensure compliance with Indian regulatory requirements.

82%

Overseeing regulatory aspects of clinical trials conducted in India, including submissions and compliance.

80%

Managing post-market surveillance activities and reporting adverse events to regulatory authorities in India.

78%

Staying updated on changes in Indian regulations and guidelines and communicating these changes to relevant stakeholders.

75%

Managing regulatory aspects throughout the product life cycle, from initial approval to renewals and variations.

72%

Preparing for and managing regulatory audits and inspections by Indian authorities.

Detailed Work Profile

Interests