Regulatory Affairs Executive

Detailed Job Role

Ensure regulatory compliance, prepare documentation for approvals, monitor regulatory changes and communicate with authorities.

KRA (Key Responsibility Areas)

Documentation submission, monitoring compliance, advising teams, record management

KPI (Key Performance Indicators)

Submission success rate, audit results, documentation accuracy, response time

Job Summary:

We are seeking a detail-oriented Regulatory Affairs Executive to ensure regulatory compliance, prepare documentation for approvals, and liaise with regulatory authorities. The ideal candidate will monitor regulatory changes, advise internal teams, and maintain accurate records to support product approvals and compliance.

Key Responsibilities:

• Prepare and submit regulatory documentation for product approvals and registrations.
• Monitor regulatory changes and ensure organizational compliance.
• Advise internal teams on regulatory requirements and product compliance.
• Maintain records of submissions, approvals, and communications with authorities.
• Support audits and inspections by regulatory bodies.
• Collaborate with R&D, QA, and production teams to ensure regulatory alignment.

Key Performance Indicators (KPIs):

• Success rate of regulatory submissions
• Compliance during audits and inspections
• Accuracy and completeness of documentation
• Timeliness of responses to regulatory queries

Skills & Competencies:

• Strong knowledge of pharmaceutical regulations and submission processes
• Attention to detail and strong documentation skills
• Analytical and problem-solving abilities
• Effective communication and collaboration skills
• Proficiency in regulatory tracking tools and MS Office

Education