Manager - International Regulatory Affairs & Licensing (New Delhi)

Manager - International Regulatory Affairs & Licensing (New Delhi)

02 Oct
|
M/S Jagat Pharma
|
New Delhi

02 Oct

M/S Jagat Pharma

New Delhi

Company Name : Jagat Pharma

Open Position : Manager/Sr. Manager - International Regulatory Affairs

Exp : 5-10years

Location - Jasola, New Delhi

Interested candidates can share their resume at [email protected]

Role Overview

The candidate should have solid experience in the Ayurvedic / Herbal / Healthcare sector and hands-on exposure to international product registration and regulatory compliance. Practical knowledge of markets such as UAE/Dubai, USA and Nepal is preferred, with the ability to research and manage requirements for additional international markets.

The role covers the complete regulatory journey: Product Concept Ingredient Review Product Development Testing & Documentation Registration / Licensing Approval Packaging & Labelling Import Compliance International Launch.

Key Responsibilities

1. International Licensing & Product Registration

- Manage end-to-end international product registration, licensing and regulatory compliance.
- Identify country-specific regulatory pathways and registration requirements.
- Prepare and coordinate product dossiers and supporting documentation.
- Manage regulatory submissions, queries, approvals and renewals.
- Coordinate with international distributors, agents, consultants, laboratories and regulatory authorities.
- Maintain country-wise databases of licences, registrations, certifications and renewal timelines.
- Conduct regulatory gap analysis before entering a new international market.

2. UAE / Dubai Regulatory Compliance

- Manage or coordinate applicable UAE / Dubai product registration and municipal regulatory requirements.
- Understand requirements for product classification, ingredients, labels, claims, packaging and supporting documents.
- Coordinate with local distributors, importers and regulatory consultants.
- Support registration, approval and import requirements before commercial launch.
- Handle regulatory queries and ensure timely completion of documentation.

Preferred: Prior hands-on experience with Dubai Municipality / UAE product registration.

3. USA / US FDA Regulatory Knowledge





- Understand applicable US FDA requirements based on the nature and classification of Ayurvedic / herbal / healthcare products.
- Evaluate whether products fall under applicable categories such as dietary supplements, cosmetics, drugs or other regulated categories.
- Review ingredients, formulations, product claims, labels and marketing communication from a regulatory perspective.
- Coordinate required documentation and regulatory activities with US consultants or partners.
- Identify regulatory risks and required changes before product development or commercial launch.

Preferred: Prior experience with US FDA-related compliance or registration of Ayurvedic / herbal / healthcare products.

4. Nepal & Other International Markets

- Manage registration and regulatory requirements for Nepal and other international markets.
- Research country-specific regulations for Ayurvedic and herbal products.
- Coordinate with local distributors, agents and regulatory consultants.
- Prepare country-specific registration checklists and documentation.
- Track regulatory submissions, queries and approvals.
- Experience in Middle East, Africa, Southeast Asia or other emerging markets will be an advantage.

5. Ayurvedic & Ingredient Regulatory Knowledge

- Review Ayurvedic ingredients and formulations from an international regulatory perspective.
- Identify ingredients that may be restricted, prohibited or subject to specific requirements in different countries.
- Review ingredient concentrations, formulation requirements and supporting evidence.
- Identify additional testing, safety or technical documentation requirements.
- Work with R&D; to make products suitable for target markets.
- Evaluate regulatory feasibility before finalizing new formulations.

Key expectation:



The candidate should be able to assess whether a formulation and its ingredients can be legally registered and marketed in the target country.

6. Eye Care / Eye Drop Regulatory Experience

Jagat Pharma has an established Eye Care portfolio. Experience with eye drops, ophthalmic or eye-care products will therefore be highly preferred.

- Understand regulatory classification of eye-care products across different countries.
- Assess registration requirements applicable to eye drops and related products.
- Review ingredient and formulation compliance, intended use and product claims.
- Coordinate testing, stability, safety and technical documentation.
- Review labelling, packaging and product literature.
- Identify country-specific regulatory pathways and additional approvals required before launch.

Important: The candidate should be able to assess claims relating to dryness, irritation, eye comfort, screen fatigue and other eye-care benefits, including the supporting documentation and country-specific restrictions applicable to such claims.

7. Product Development & International Launch

- Review proposed products from an international regulatory feasibility perspective at the development stage.
- Review ingredients before formulation finalization and recommend changes where required.
- Review product claims and intended use.
- Coordinate product testing and technical documentation.
- Review labels, packaging and product literature.
- Develop country-wise regulatory launch checklists.
- Coordinate with R&D;, Quality, Manufacturing, Packaging, Marketing and International Business teams.
- Ensure regulatory requirements are completed before shipment and commercial launch.

Interested candidates can share their resume at [email protected]

About Jagat Pharma

Jagat Pharma is an Ayurvedic and natural healthcare company with a growing portfolio across Eye Care, Wellness, Sexual Wellness and other Ayurvedic / Herbal categories. As part of our international expansion, we are looking for an experienced professional to manage international regulatory affairs, product registrations, licenses, certifications and the regulatory aspects of product development and international launches.

📌 Manager - International Regulatory Affairs & Licensing (New Delhi)
🏢 M/S Jagat Pharma
📍 New Delhi

Reply to this offer

Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.

Subscribe to this job alert:

Get the latest job offers by email for: manager - international regulatory affairs & licensing (new delhi) / new delhi

Subscribe to this job alert:

Get the latest job offers by email for: manager - international regulatory affairs & licensing (new delhi) / new delhi