Executive- RA API

USV; Maharashtra; Presencial; INR 1 200 000 - 2 000 000; Tempo integral

Resumo da oferta

USV seeks a Regulatory Affairs professional to manage strategic filing initiatives, including DMF and CEP submissions, and oversee the complete lifecycle of regulatory documents. You will ensure timely approvals, maintain quality documentation, and support business continuity across markets.

Responsibilities include handling pre-approval filings, responding to deficiency notices, managing change control, and preparing post-approval amendments with cross-functional teams and health authority

Qualificações

• 4–7 years hands-on experience in Regulatory Affairs.
• DMF and CEP filing experience required.
• Strong knowledge of ICH Guidelines, GMP and regional requirements for US, EU, and Emerging Markets.
• Experience with eCTD publishing tools and document management systems.

Responsabilidades

• Pre-approval - Prefilling Support and New DMF / CEP Fillings: review pre-filling docs with deadlines.
• Pre-approval - Deficiency Responses: review comments and meet timelines.
• Change control, Vendor Notifications and Deviations: assess impact on submissions.
• Post Approval - DMF / CEP Amendments and Annual reports: ensure lifecycle changes are approved and submitted on time.
• Support to cross functional team: regulatory guidance to sites, audits, and stakeholder communications.

Conhecimentos

Regulatory Affairs

Attention to detail

Negotiation skills

Cross-functional collaboration

Formação académica

Master’s in Chemistry/Life Sciences

RAC certification

Ferramentas

eCTD Publishing

EDMS / DMS

Descrição da oferta de emprego

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.