Executive- API RA

USV PRIVATE LIMITED; Maharashtra; Presencial; INR 1 200 000 - 1 800 000; Tempo integral

Resumo da oferta

USV PRIVATE LIMITED is seeking a Regulatory Affairs professional to manage DMF/CEP filings and lifecycle activities. The role involves pre-approval prefilling, deficiency responses, and coordinating with R&D, QA, and manufacturing sites to ensure timely submissions. Candidates should have 4–7 years in Regulatory Affairs with strong ICH/GMP knowledge and experience in US/EU regulatory frameworks.

Qualificações

• 4–7 years of hands-on Regulatory Affairs experience.
• Proven DMF/CEP filing experience and lifecycle management.
• Strong knowledge of ICH Guidelines and GMP requirements.
• Understanding US, EU, and emerging/regional regulatory requirements.

Responsabilidades

• Lead pre-approval activities for DMF/CEP filings with timely submissions.
• Manage deficiency responses and stakeholder reviews within deadlines.
• Oversee change control, vendor notifications, deviations, and impact assessments.
• Support post-approval changes, variations, and annual reporting.
• Coordinate with R&D, QA, Manufacturing sites and external customers on regulatory matters.

Conhecimentos

Regulatory Affairs

Documentation & filings

Stakeholder management

Attention to detail

Formação académica

Master's degree in Chemistry or Life Sciences

Ferramentas

eCTD publishing tools

Document management systems

Descrição da oferta de emprego

Job Description

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

Role Objective:

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.

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.

Educational Qualification

Academic Qualifications & Certifications

Master’s degree in Chemistry or related Life Sciences.

Professional certification in Regulatory Affairs (e.g., RAC) is a significant advantage.