Job Responsibilities

Regulatory Strategy Development

Identifying the most efficient regulatory pathway for drug approval.

Preparing a comprehensive plan to comply with international regulatory requirements.

Advising on timelines, documentation, and submission requirements.

Understanding the nuances of different regulatory bodies is crucial for developing strategies that minimize delays and maximize approval success.

Preparation and Submission of Regulatory Documents

A core responsibility of DRA professionals is preparing, reviewing, and submitting regulatory documents to authorities.

Attention to detail and knowledge of submission platforms, such as CTD (Common Technical Document), are essential.

Liaising with Regulatory Authorities

Responding to queries and requests for additional information.

Attending meetings with regulatory agencies to discuss the drug development process.

Ensuring compliance with post-approval changes and modifications.

Building strong relationships with regulatory agencies helps facilitate smoother approval processes.

Monitoring Regulatory Compliance

Conducting periodic audits and inspections.

Managing post-market surveillance activities.

Reviewing and submitting periodic safety update reports (PSURs).

Ensuring compliance with pharmacovigilance and adverse event reporting.

Staying updated on regulatory changes and proactively managing compliance

Labeling and Advertising Compliance

Reviewing and approving product labels, ensuring accurate information.

Ensuring that advertising and marketing materials meet legal and ethical standards.

Addressing labeling updates required by regulatory agencies.

Risk Management and Mitigation

Identify and assess potential risks associated with pharmaceutical products.

Develop strategies to mitigate these risks.

Monitor and evaluate the effectiveness of risk management strategies.

Domestic Regulatory Activates

Uploading the documents on SUGAM portal and on the portals of other State Regulatory Authorities.

Handling and responding to all the product specific queries to the related drug departments.

Ensuring overall compliance to domestic regulatory requirements.

Co-ordination with respective departments.

Maintaining familiarity with company product ranges.

Keeping up to date with changes in regulatory legislation and guidelines.

Ensuring that quality standards are met and submissions meet strict deadlines.

Maintain high levels of accuracy, meet tight deadlines.

Regulatory Affairs Manager