# Regulatory Affairs Post-Approval Manager - DEMO Global Services Center

> Demo S.A. · Hyderabad, India · Full-time · Posted 2026-02-25

**Workplace:** on_site

## Description

At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented **Regulatory Affairs Post-Approval Manager** to join our team. The candidate will be responsible for execution of post-marketing regulatory activities **for MENA region, CIS, Asia-Pacific and others global markets.**

This role involves ensuring continuous product compliance, managing post-market submissions, and providing strategic regulatory guidance across these diverse and evolving markets. The manager acts as the primary liaison between the company and health authorities/business partners in the applicable regions. This position is based at **Hyderabad, India.**

**Responsibilities:**

-   Oversee the planning, authoring, coordination, and submission of post-approval variations and responding health authorities for marketing authorisation applications.
-   Regulatory Strategy: Evaluation of change proposals and providing the regulatory strategy for assigned regulatory projects for sterile (small & large volume parenteral, aqueous solution, lyophilized product, sterile powder, infusion bag etc.), non-sterile and oral solid/liquid products.
-   Gap analysis of approved marketing authorisation for new regulatory requirements for quality and labeling updates required and submission of variations according to the predefined priorities.
-   Managing the responses to deficiency letters and other CMC-related regulatory queries.
-   Cross-functional Collaboration: Working closely with global teams across R&D, manufacturing, quality, labelling and collection of the documents for preparation of post-approval submissions.
-   Regulatory Compliance: Monitor and interpret changes in local legislation, guidelines, and industry trends across the MENA, CIS, and Asia-Pacific regions etc., translating these into actionable steps for the organization to ensure ongoing compliance.
-   Identify and escalate the risks associated with regulatory submissions and projects to superiors.

## Requirements

-   Master or Bachelor degree in Pharmacy.
-   **12+ years in regulatory affairs, with at least 8 years on post-approval activities, including variations and lifecycle management for MENA region, CIS, Asia-Pacific and others global markets.**
-   Sound understanding of Sterile and Oral solid/liquid dosage form.
-   Thorough knowledge of post-marketing regulatory submissions across global market.
-   Ability to influence cross-functionally and negotiate with regulators.
-   Strong project management skills for coordinating and balancing multiple priorities.

## Benefits

The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.

## Apply

[Apply at Demo S.A.](https://apply.workable.com/demo-s-dot-a/j/381CC4AA28/apply)

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