Role Objective The role will be responsible for preparing, reviewing, and filing high-quality regulatory dossiers for Formulations in targeted Emerging Markets and Rest of World (ROW) regions. This role ensures strict compliance with country-specific regulatory guidelines, manages post-approval product lifecycles, coordinates with internal technical teams, and handles client and health authority queries to secure timely market approvals.

Key Responsibilities:

Dossier Management: Collate, prepare, and file dossiers accurately and on time for Formulations and API products to obtain licenses in targeted Emerging Markets/ROW regions.

Compilation & Publishing: Perform e-CTD compilation, publishing, and submission of DMFs and dossiers to customers or Health Authorities.

Document Checklists: Prepare comprehensive documentation checklists for regulatory filings customized to country-specific regulatory requirements.

Lifecycle Maintenance: Manage submissions for product renewals, re-registrations, and tender filings across assigned regions.

Technical Documentation Review: Collate and conduct first-level reviews of technical documentation, including stability data, Technical Transfer Documents (TTD), Pharmaceutical Development Reports (PDR), and method validation reports.

Specifications Review: Conduct initial regulatory reviews of specifications for APIs, semi-finished products, and finished drug products.

Artwork & Labeling: Review labeling and artwork for Formulations to ensure compliance with specific market requirements.

Change Control Management: Review and perform regulatory impact analyses on internal change controls, proposed post-approval changes, and vendor-notified changes per country-specific guidelines.

Amendments & Supplements:



Prepare and file post-approval amendments, supplements, and annual reports to ensure continuous compliance.

Query Resolution: Assist in assessing and resolving technical queries received from customers, agencies, and regulators before escalating/sharing with the team lead.

Site Coordination: Share copy archives of all agency submissions for APIs and approved registration packages for Finished Dosage Forms (FDF) with respective manufacturing sites.

STAKEHOLDER INTERACTION

Type of Interaction: Internal

Interaction with: Cross-functional teams (QA/QC, R&D;, Tech Transfer, Manufacturing Sites) & Team Lead

Nature of Interaction: Coordinating for technical documentation, reviewing stability/PDR/method validations, sharing approval packages, and evaluating change controls.

Type of Interaction: External

Interaction with: Health Authorities, Regulatory Agencies, Customers, Vendors

Nature of Interaction: Communicating change control notifications/approvals, submitting dossiers/e-CTD files, and clarifying regulatory queries

JOB REQUIREMENTS

Skilled Experience and Relevant Skills

Experience: 3–5 years of core experience Regulatory Affairs focusing on Emerging Markets / ROW for Formulations

- Hands-on expertise in e-CTD compilation, publishing, and dossier management.
- Strong knowledge of post-approval lifecycle management, including change control evaluation, amendments, and renewal filings.
- Demonstrated ability to conduct first-level technical reviews of PDR, TTD, analytical method validations, and artwork.
- Sound analytical and problem-solving skills to address regulatory agency queries effectively.

Academic Qualifications & Certifications Educational Qualification: M.Pharm only

📌 Senior Officer - Regulatory Affairs - Emerging Markets (India)
🏢 USV
📍 India