Regulatory Affairs Manager

Greetings from Vigilare BioPharma!

We’re Hiring! Join Our Team

Position:

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Job Responsibilities:

We are seeking an experienced Regulatory Affairs Manager with a strong background in ANDA submissions and US FDA compliance. The ideal candidate will lead the preparation and management of regulatory filings, particularly ANDAs and post-approval submissions, while working cross-functionally to ensure timely and compliant product approvals. The role also involves mentoring junior staff, driving regulatory intelligence initiatives, and supporting strategic client interactions.

Key Responsibilities:

• Manage the end-to-end preparation and submission of Abbreviated New Drug Applications (ANDAs) and related post-approval submissions including Annual Reports, Complete Response Letters (CRLs), and Information Requests (IRs).
• Coordinate with cross-functional teams (R&D, Quality, Manufacturing, Packaging, Marketing) to collect required data and documentation for timely regulatory submissions.
• Review and compile CMC documentation in compliance with FDA guidelines; ensure manufacturing and control processes meet regulatory expectations.
• Lead and mentor junior regulatory team members, ensuring best practices and knowledge transfer.
• Identify regulatory risks early and implement mitigation strategies across multiple product portfolios.
• Collaborate with internal stakeholders to maintain regulatory compliance throughout product lifecycle, including change control management.
• Implement and manage regulatory change control processes; assess the impact of technical, formulation, or packaging changes on product registration status.
• Maintain up-to-date knowledge of US FDA regulations, GDUFA, MAPPs, ICH guidelines, and other relevant regulatory frameworks.
• Provide regulatory input during promotional material reviews to ensure compliance with FDA’s OPDP and advertising regulations.
• Support regulatory filings and life cycle maintenance for products in semi-regulated and ROW (Rest of World) markets.
• Address client inquiries related to regulatory processes, submission strategies, and compliance requirements.
• Assist in identifying potential clients and contribute to business development efforts, including proposal and strategy development for regulatory services.

Qualifications & Skills:

• Master’s degree in Pharmacy, Chemistry, Life Sciences, or related field.
• Experience: 8 to 10 + Years of hands-on experience in US FDA regulatory submissions, especially ANDA dossier compilation and lifecycle management.
• Strong understanding of eCTD structure, FDA portals (ESG, CDER NextGen), SPL submissions, and labeling requirements.
• Proven experience in change control assessment, regulatory impact analysis, and risk-based submission planning.
• Excellent communication skills, with the ability to liaise with internal teams and external stakeholders.
• Strong leadership and team mentoring capabilities.
• Working knowledge of regulatory pathways in semi-regulated and ROW markets is a plus.

Preferred Tools/Systems:

• FDA ESG, CDER NextGen Portal
• Pharmaready, Veeva Vault, Extedo eCTD Manager (or similar EDMS/eCTD tools)
• Regulatory Intelligence platforms (e.g., Cortellis, Elsevier PharmaPendium)

Mail to hr@vigilarebp.com

If you're passionate about drug safety and medical information handling—this is your chance to make an impact in global healthcare.

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