# Regulatory Affairs Post-approval Senior Associate-Europe - DEMO Global Services

**Company:** [Demo S.A.](http://jobs.workable.com/companies/bfFZ3SuxMR5zjdkBWmB1yU.md)
**Location:** Hyderabad, India
**Workplace:** on site
**Employment type:** Full-time
**Department:** Regulatory Affairs

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## Description

At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented **Regulatory Affairs Senior Associate** to join our team. The job responsibilities for this position includes post-marketing regulatory submissions for **Europe** and other global markets for sterile, non-sterile and oral solid/liquid products. **This position is based at Hyderabad, India.**

**Responsibilities:**

-   Understanding of Regulatory strategy and documentation requirements for EU variations including renewals, extensions for Sterile (SVP, LVP, lyophilized, ophthalmic etc.), non-sterile and oral solid/liquid products.
-   Collect, prepare, compile regulatory documentation, for the product’s lifecycle maintenance (administrative, quality, safety variations and renewal procedures).
-   Prepare and coordinate responses to Deficiency Letters (DLs) and other CMC-related regulatory queries in collaboration with cross-functional teams
-   Preparation of module 1 documentation for as per assigned timelines for out-licensing and in-licensing products in EU countries
-   Liaise with various departments to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration
-   Liaise with external Regulatory authorities as required
-   Act as responsible Regulatory Team member for assigned regulatory projects
-   Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products

## Requirements

-   Bachelor or Master Degree in Pharmacy with **6-9 years of experience** in Regulatory Affairs / CMC within a Pharmaceutical organization.
-   Knowledge of CMC and global regulatory guidelines for Sterile (small & large volume parenteral, aqueous solution, lyophilized product, sterile powder etc) and oral solid/liquid dosage form.
-   Strong organization skills, multi-tasking and able to meet deadlines.
-   Effective communication and relationship management.
-   Ability to work under pressure, resilience.

## Benefits

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