Regulatory Affairs Manager

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.