Sr Manager - Regulatory Affairs - CMC - US Market

Drlogy; Gurugram District; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

Drlogy is seeking an experienced Sr. Manager – Regulatory Affairs to lead Chemistry, Manufacturing, and Controls (CMC) regulatory activities for pharmaceutical products targeting the US market. The role involves preparing regulatory submissions, ensuring compliance with USFDA guidelines, and coordinating with cross-functional teams for successful product registrations.

The ideal candidate should have experience in lifecycle management, dossier review, and regulatory strategies. Further responsibilities include mentoring team members and driving process improvements.

Qualifications

• Experience managing Chemistry, Manufacturing, and Controls (CMC) regulatory activities.
• Skilled in preparing regulatory submissions and lifecycle management.
• Adept at coordinating with cross‑functional teams.

Responsibilities

• Lead CMC regulatory affairs activities for pharmaceutical products intended for the US market.
• Prepare, review, and submit regulatory dossiers including ANDA and NDA.
• Ensure compliance with USFDA guidelines and submission requirements.

Job description

Sr Manager – Regulatory Affairs – CMC – US Market

Experienced Sr. Manager – Regulatory Affairs – CMC – US Market responsible for managing Chemistry, Manufacturing, and Controls (CMC) regulatory activities for pharmaceutical products targeting the US market. Skilled in preparing regulatory submissions, lifecycle management, dossier review, and compliance with USFDA requirements. Adept at coordinating with cross‑functional teams to support product registrations, post‑approval changes, technical documentation, and regulatory strategies ensuring timely approvals and sustained compliance.

Responsibilities

• Lead CMC regulatory affairs activities for pharmaceutical products intended for the US market.
• Prepare, review, and submit regulatory dossiers including ANDA, NDA, supplements, and amendments.
• Ensure compliance with USFDA guidelines, regulatory standards, and submission requirements.
• Coordinate with R&D, manufacturing, quality assurance, analytical, and packaging teams for CMC documentation.
• Manage lifecycle maintenance activities including variations, renewals, and post‑approval submissions.
• Review technical documents related to formulation, manufacturing processes, specifications, and stability data.
• Evaluate regulatory impact of product changes and support change control activities.
• Monitor evolving US regulatory requirements and implement necessary compliance updates.
• Support responses to regulatory queries, deficiency letters, and agency communications.
• Participate in regulatory audits, inspections, and compliance assessments.
• Maintain regulatory databases, submission trackers, and documentation records accurately.
• Drive process improvements to enhance submission quality and regulatory efficiency.
• Coordinate with external partners, consultants, and contract manufacturing organizations when required.
• Provide regulatory guidance to internal stakeholders during product development and commercialization.
• Mentor and guide regulatory affairs team members on US CMC regulatory practices and compliance standards.