Executive- API RA

USV; Maharashtra; On-site; INR 900,000 - 1,300,000; Full time

Job summary

USV is seeking a Regulatory Affairs professional with 4-7 years of hands-on experience to manage DMF and CEP filings across US, EU, and emerging markets. You will ensure timely submissions, review technical data, and guide cross-functional teams through a complex regulatory landscape.

The role requires strong knowledge of ICH guidelines, GMP, and experience with eCTD publishing tools, with a focus on accuracy and lifecycle management of filings.

Qualifications

• 4-7 years of hands-on regulatory affairs experience.
• Proven DMF and CEP filing experience.
• Strong understanding of ICH guidelines and GMP.
• Experience with US, EU, and Emerging Markets regulatory requirements.
• Proficient with eCTD publishing and document management systems.

Responsibilities

• Pre-approval - Prefilling support and DMF/CEP fillings with timelines.
• Pre-approval - Review deficiency responses to meet submission timelines.
• Change control, vendor notifications and deviations impact assessment.
• Post-approval changes, annual reports, lifecycle change approvals.
• Support to cross-functional teams and audits, regulatory guidance to sites.

Skills

Regulatory Affairs

DMF filings

CEP filings

ICH GMP knowledge

eCTD publishing tools

Documentation management

Attention to detail

Regulatory negotiations

Education

Master's degree in Chemistry or Life Sciences

Tools

eCTD tools

Document management systems

Job description

This role focuses on strategic filing (DMF/CEP), maintaining the complete lifecycle of submissions through quality documentation, timely approvals and business continuity.

KEY RESPONSIBILITIES

• Pre-approval - Prefilling Support and New DMF / CEP Fillings: Review of the various Pre-filling documents [TTD / Process / Specifications / Validations / Stability ext.] with agreed timelines. Meeting submission timelines of assigned projects for identified markets.
• Pre-approval - Deficiency Responses: Review comments of the various response documents with agreed timelines with stakeholders. Meeting submission timelines of assigned projects for identified markets.
• Change control, Vendor Notifications and Deviations: Review of change controls, deviations, vendor notifications and their impact assessment on the submissions.
• Post Approval - DMF / CEP Amendments [Post approval changes / variations], Annual reports: Meeting submission timelines of assigned projects for identified markets and approval of the life cycle changes for business continuity.
• Support to cross functional team: Handling of Customer requests, Regulatory support / guidance to all manufacturing sites, cross functional team, Health Authority Audits, Quality agreement review.

STAKEHOLDER INTERACTION

• Type of Interaction: Internal
• Interaction with: R&D, QC, QA, Manufacturing Sites, Projects management.
• Nature of Interaction: Gathering technical data, document review, technical discussions for DMF / CEP filings, amendments, responses.
• Type of Interaction: Internal & External
• Interaction with: Cross functional team & external customers
• Nature of Interaction: Submission of dossiers, defending technical queries, and notifying stakeholders of regulatory changes.

JOB REQUIREMENTS

Professional Experience and Relevant Skills

• 4-7 years of hands-on experience in Regulatory Affairs.
• Domain Expertise: Proven experience in filing Drug Master Files (DMF) and Certificates of Suitability (CEP).
• Regulatory Knowledge: Deep understanding of ICH Guidelines, GMP (Good Manufacturing Practices), and regional requirements for US, EU, and Emerging Markets.
• Software Proficiency: Hands-on experience with eCTD publishing tools and document management systems.
• Soft Skills: High attention to detail, strong negotiation skills for dealing with agencies, and the ability to translate complex technical data into clear regulatory narratives.

Academic Qualifications & Certifications

Educational Qualification:

• Master's degree in Chemistry or related Life Sciences.
• Professional certification in Regulatory Affairs (e.g., RAC) is a significant advantage.