Assistant Manager - Regulatory Affairs (US)

We are seeking a highly skilled Assistant Manager - Regulatory Affairs to specialize in the US market. The ideal candidate will have thorough knowledge of CMC and Module 1 requirements, with a strong background in managing the full lifecycle of drug products. This role is crucial for the authoring, review, and submission of ANDAs, as well as handling post-approval changes and maintaining regulatory compliance. You will be responsible for coordinating with various teams to ensure all regulatory strategies are met in a timely manner.

Key Responsibilities

• Drug Dossier Management: Author, review, and submit ANDAs, and handle DMF review and assessment.
• Product Lifecycle Management (LCM): Manage post-approval activities such as the assessment of changes, and the timely submission of annual reports, CBE-30, and PAS.
• Labeling & Artwork: Prepare and submit labeling files, including SPL preparation, and review and finalize artworks (PIL, labels) according to current guidelines.
• eCTD Publishing: Oversee the electronic submission of all regulatory documents through eCTD publishing.
• Query & Coordination: Evaluate and respond to queries for under-review ANDAs within strict timelines. Coordinate with R&D, API vendors, and other cross-functional teams to gather necessary data for regulatory filings.
• Regulatory Intelligence: Maintain up-to-date knowledge of technical guidelines and regulatory requirements to ensure compliance.
• Reporting & Maintenance: Review technical documents from various departments and maintain accurate regulatory files and databases.

Qualifications & Skills

• Proven experience in regulatory affairs with a focus on the US market.
• Thorough knowledge of CMC and Module 1 requirements for drug submissions.
• Expertise in ANDA and DMF processes.
• Strong understanding of post-approval changes and submissions.
• Proficiency in eCTD publishing and SPL preparation.
• Excellent coordination skills and the ability to work effectively with cross-functional teams.
• Strong attention to detail and a proactive approach to regulatory intelligence.