Role Objective:

The primary objective of this role is to facilitate the timely market entry of drug products by preparing high-quality, compliant regulatory submissions. You will act as a bridge between technical departments and regulatory bodies, ensuring that all documentation aligns with current country-specific guidelines and internal quality standards.

KEY RESPONSIBILITIES

- Dossier Management & Filing: Collate, prepare, and file accurate dossiers for formulations and drug products to secure licenses in targeted markets.

- Documentation & Compliance: Develop comprehensive checklists for regulatory filings based on current, country-specific requirements.

- Technical Review: Conduct first-level reviews of critical technical documentation, including:

1. Stability data, Technical Transfer Documents (TTD), and Pharmaceutical Development Reports (PDR).
- Analytical method validations.
- BMR/ BPR, Hold time report, process validation report etc
- Specifications for API, Semi-Finished, and Finished Products.

- Artwork & Labeling: Perform initial reviews of labeling and artwork to ensure strict adherence to the regulations of the filing market.

- Change Control & Impact Analysis: Analyze the regulatory impact of internal change controls and communicate necessary notifications/approvals to customers.

1. Evaluate vendor-notified changes against country-specific requirements.
- Lifecycle Management:



Assess post-approval changes and prepare necessary amendments, supplements, or annual reports to maintain continuous compliance.

- e-CTD Publishing: Manage the compilation and publishing of e-CTD DMFs/Dossiers for submission to Health Authorities and customers.

- Query Resolution: Assist in resolving queries from regulators or customers, assessing technical responses before escalating to the Team Leader.

- Facility Registration: Prepare and e-file documents for USFDA facility registrations.

STAKEHOLDER INTERACTION

Type of Interaction: Internal

Interaction with: R&D;, Quality Control, Manufacturing, and Quality Assurance teams.

Nature of Interaction: Collaborating to gather technical data, reviewing stability reports, and communicating change control impacts.

Type of Interaction: External

Interaction with: Customers, and Raw Material Vendors.

Nature of Interaction: Submitting dossiers, addressing regulatory queries, and reviewing vendor-notified technical changes.

JOB REQUIREMENTS

Professional Experience and Relevant Skills

- 3–7 years of hands-on experience in Regulatory Affairs.

- Robust familiarity with US market regulatory pathways (ANDA/NDA) and USFDA guidelines.

Academic Qualifications & Certifications

- Educational Qualification: Master of Pharmacy only.

📌 Senior Officer - Regulatory Affairs (Maharashtra)
🏢 USV
📍 Maharashtra