Assistant Manager, Regulatory Affairs

Growth For Impact; India; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Growth For Impact in India is seeking a Regulatory Affairs expert to ensure CTD/eCTD accuracy for biosimilars and biologics, lead responses to regulatory queries, and shape development and lifecycle strategies.

You will collaborate with R&D, QA, Manufacturing and Pharmacovigilance to ensure compliance with US/EU/ICH guidelines, manage global lifecycle activities, and assess regulatory impact of changes.

Qualifications

• CTD/eCTD modules must be accurate and complete, with emphasis on CMC documentation for biologics and biosimilars.
• Regulatory responses to queries and deficiency letters must meet defined timelines.
• Regulatory strategy input for development, registration, and lifecycle management of biosimilars/biologics.
• Collaborate across R&D, QA, Manufacturing, and Pharmacovigilance to ensure lifecycle compliance.

Responsibilities

• Ensure accuracy and completeness of CTD/eCTD modules with focus on CMC documentation for biologics/biosimilars.
• Lead responses to regulatory queries, information requests, and deficiency letters within stipulated timelines.
• Contribute to regulatory strategy for development, registration, and lifecycle management of biosimilars/biologics.
• Support planning of comparability protocols, analytical similarity strategy, clinical study design justification, and CMC development from a regulatory perspective.
• Provide regulatory intelligence and assess impact of new or updated US/EU/ICH guidelines relevant to biologics and biosimilars.
• Manage global lifecycle activities including post-approval changes, variations, supplements, label updates, renewals, and annual reports.
• Evaluate change controls to determine global regulatory impact and required submissions.
• Collaborate with R&D, Process Development, Analytical, Quality Assurance, Manufacturing, Clinical, and Pharmacovigilance teams to ensure regulatory compliance throughout the product lifecycle.
• Participate in technical review meetings and provide regulatory assessments for changes, deviations, and investigations.
• Ensure compliance with global regulations, ICH guidelines, biosimilar-specific pathways, and regional

Job description

ROLE

• Ensure accuracy and completeness of CTD/eCTD modules with focus on CMC documentation for biologics/biosimilars.
• Lead responses to regulatory queries, information requests, and deficiency letters within stipulated timelines.
• Contribute to regulatory strategy for development, registration, and lifecycle management of biosimilars/biologics.
• Support planning of comparability protocols, analytical similarity strategy, clinical study design justification, and CMC development from a regulatory perspective.
• Provide regulatory intelligence and assess impact of new or updated US/EU/ICH guidelines relevant to biologics and biosimilars.
• Manage global lifecycle activities including post-approval changes, variations, supplements, label updates, renewals, and annual reports.
• Evaluate change controls to determine global regulatory impact and required submissions.
• Collaborate with R&D, Process Development, Analytical, Quality Assurance, Manufacturing, Clinical, and Pharmacovigilance teams to ensure regulatory compliance throughout the product lifecycle.
• Participate in technical review meetings and provide regulatory assessments for changes, deviations, and investigations.
• Ensure compliance with global regulations, ICH guidelines, biosimilar-specific pathways, and regional