About the job

Position: Regulatory Affairs Manager

Location: Hyderabad

Qualification: B.Pharm / M.Pharm/ Pharm.D

Experience: 8 to 10 + Years

Shift: 2pm-11pm IST

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)