Manager - Regulatory Affairs - Domestics

USV PRIVATE LIMITED; Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

USV PRIVATE LIMITED in Mumbai is seeking a Regulatory Affairs Manager to oversee the licensing process. You will ensure compliance by managing licenses for manufacturing units and CNF locations, and your responsibilities will include coordinating submissions for government tenders. The ideal candidate will have 10-16 years of experience in Domestic Regulatory Affairs with excellent attention to detail and a proactive approach in tracking regulatory tasks. Experience with Indian regulatory frameworks is essential.

Qualifications

• 10 - 16 years of experience in Domestic Regulatory Affairs.
• Proven experience in handling Indian regulatory filings and FDA liaisoning.
• Strong proactive approach in tracking pending tasks with external authorities.

Responsibilities

• Manage and streamline the end-to-end regulatory licensing process.
• Compile and submit licensing applications and renewals.
• Maintain and track drug licenses for all CNF locations and manufacturing sites.

Skills

Regulatory expertise

Proactive follow-up

Attention to detail

Experience with Indian regulatory filings

Coordination skills

Job description

The primary objective of this role is to manage and streamline the end-to-end regulatory licensing process for USV Private Limited. The incumbent will be responsible for ensuring that all manufacturing units, CNF locations, and external partners maintain valid drug licenses and certifications, thereby ensuring uninterrupted business operations and legal compliance.

KEY RESPONSIBILITIES

• Licensing & Documentation: Compile and submit high-quality licensing applications for fresh licenses, renewals, test licenses, and Certificates of Pharmaceutical Products (COPP) in standard formats.
• Compliance Management: Ensure all documentation is completed accurately to receive essential licenses and certificates as per statutory requirements.
• Operational Oversight: Maintain and track drug licenses for all Carrying & Forwarding (CNF) locations and manufacturing sites.
• Supply Chain Support: Issue Brand No Objection Certificates (NOCs) to supply chain departments to facilitate "Principal to Principal" (P to P) licensing.
• Tender Support: Prepare and organize all necessary regulatory documentation required for the successful submission of government and private tenders.
• Record Keeping: Maintain a meticulous and centralized archive of all licenses, certificates, and regulatory correspondence.

Type of Interaction: Internal

Interaction with: Internal Departments (R&D, Quality, Manufacturing), Supply Chain, and Commercial teams.

Nature of Interaction: Collaborating to gather relevant technical data for applications and providing Brand NOCs to support logistics and supply chain workflows

Type of Interaction: External

Interaction with: Food and Drug Administration (FDA) authorities, Loan License (LL) locations, Third Party (TP) manufacturers, and CNF agents.

Nature of Interaction: Proactive follow‑ups for pending FDA approvals and jobs across various locations (Baddi, Daman, etc.) and coordinating with external manufacturers for timely license renewals

JOB REQUIREMENTS

Professional Experience and Relevant Skills

• Required 10 - 16 years of experience in Domestics Regulatory Affairs
• Regulatory Expertise: Proven experience in handling Indian regulatory filings and FDA liaisoning.
• Follow-up & Coordination: Strong proactive approach in tracking pending tasks with external authorities and manufacturing sites.
• Attention to Detail: High level of accuracy in documentation and records management to ensure 100% compliance.
• Location Familiarity: Experience dealing with regulatory bodies in hubs such as Baddi, Daman, and various LL/TP locations