Assistant General Manager Regulatory Affairs

Key Responsibilities

• Develop and execute regulatory strategies for US formulation products across the product lifecycle.
• Prepare, review and manage ANDA/NDA submissions, amendments, supplements and other US regulatory filings.
• Handle USFDA submissions and regulatory correspondence, including deficiency responses and queries.
• Coordinate preparation and compilation of CTD/eCTD dossiers, particularly CMC-related sections.
• Review formulation development, manufacturing, analytical, stability and technical documentation for regulatory compliance.
• Provide regulatory guidance to R&D, Formulation, Analytical, QA, Manufacturing and other cross-functional teams.
• Manage post-approval regulatory activities, including supplements, variations, annual reports, site changes and other lifecycle management activities.
• Support responses to USFDA deficiencies, information requests and regulatory observations.
• Track submission timelines, commitments and regulatory deliverables to ensure timely filing.
• Review proposed changes for regulatory impact and recommend appropriate filing strategies.
• Monitor changes in USFDA regulations, guidance documents and regulatory expectations and assess their impact on the product portfolio.
• Coordinate with internal teams and external consultants/partners, wherever required.
• Mentor and guide junior regulatory professionals and contribute to team capability development.

Key Skills & Expertise

• Strong experience in US Regulatory Affairs Formulations.
• Hands-on experience with USFDA / ANDA regulatory submissions.
• Strong knowledge of USFDA regulations, guidance and submission requirements.
• Experience in CTD/eCTD dossier preparation and review.
• Expertise in CMC regulatory documentation for pharmaceutical formulations.
• Experience handling post-approval submissions and lifecycle management.
• Strong understanding of formulation development, manufacturing, analytical and stability requirements.
• Ability to independently manage regulatory projects and cross-functional deliverables.
• Strong communication, analytical and stakeholder-management skills.

Candidate Profile

• 10 - 15 years of relevant experience in Regulatory Affairs within the pharmaceutical industry.
• Strong exposure to the US market and USFDA regulatory submissions is mandatory.
• Experience specifically in pharmaceutical formulations / generic products preferred.
• Qualification: B.Pharm / M.Pharm / M.Sc.
• Candidates with experience in ANDA filings, USFDA responses and post-approval regulatory activities will be preferred.
• Mumbai-based candidates or candidates willing to relocate to Mumbai are preferred.