International Regulatory Affairs Manager

Privi; Navi Mumbai; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Privi in Navi Mumbai seeks an experienced Regulatory Affairs professional to manage global product registrations and related compliance. You will coordinate with R&D, Quality, Manufacturing, and Supply Chain to assemble dossiers and ensure timely filings.

You will liaise with consultants, government bodies, and agencies to expedite approvals, address queries, and support overseas manufacturing and R&D setups. Prior regulatory experience is essential.

Responsibilities

• Prepare, draft, and submit regulatory dossiers and applications for product registration across international markets within defined timelines; ensure proper follow-up and coordination with concerned teams.
• Liaise with external consultants, government bodies, and regulatory agencies to expedite approvals and resolve queries efficiently.
• Collaborate with internal teams including R&D, Quality, Manufacturing, and Supply Chain to gather necessary data for dossiers, technical documents, and compliance reports.
• Support the set-up of new manufacturing and R&D units abroad by preparing regulatory documentation, engaging with local authorities, and ensuring compliance with global standards.
• Manage state-wise and country-specific licensing requirements, including Provisional Registrations, Standardization of Specifications, Form G2/G3 filings, and permissions across multiple regions.
• Handle Show Cause Notices, regulatory inspections, and post-registration issues, preparing replies and attending hearings on behalf of the organization.
• Track changes in international regulations, ensuring updates are communicated and compliance strategies are adjusted accordingly.
• Maintain regulatory databases, submission trackers, and audit-ready documentation in line with industry best practices.
• Provide guidance and training to internal teams on regulatory requirements and submission procedures.

Skills

Interpretation & Analysis

Product Development

Data Validation

Analytical Skills

Presentation Skills

Job description

Role & responsibilities

1. 1. Prepare, draft, and submit regulatory dossiers and applications for product registration across international markets within defined timelines; ensure proper follow-up and coordination with concerned teams.
2. 2. Liaise with external consultants, government bodies, and regulatory agencies to expedite approvals and resolve queries efficiently.
3. 3. Collaborate with internal teams including R&D, Quality, Manufacturing, and Supply Chain to gather necessary data for dossiers, technical documents, and compliance reports.
4. 4. Support the set-up of new manufacturing and R&D units abroad by preparing regulatory documentation, engaging with local authorities, and ensuring compliance with global standards.
5. 5. Manage state-wise and country-specific licensing requirements, including Provisional Registrations, Standardization of Specifications, Form G2/G3 filings, and permissions across multiple regions.
6. 6. Handle Show Cause Notices, regulatory inspections, and post-registration issues, preparing replies and attending hearings on behalf of the organization.
7. 7. Track changes in international regulations, ensuring updates are communicated and compliance strategies are adjusted accordingly.
8. 8. Maintain regulatory databases, submission trackers, and audit-ready documentation in line with industry best practices.
9. Provide guidance and training to internal teams on regulatory requirements and submission procedures.

Preferred candidate profile

1. 1. Interpretation and Analysis of the data.
2. 2. Product Development
3. 3. Validation of data
4. 4. Analytical Skills
5. 5. Presentation Skills.