# Regulatory Affairs Senior Associate (Pre - Approval) - 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

[Apply for this job](http://jobs.workable.com/view/23c5fa6d-85c8-44aa-959c-31c3809631c4)

## Description

The **Regulatory Affairs** **Senior Associate** will work at the interface of R&D and Regulatory, building a genuine technical understanding of the product's formulation and analytical profile to support sound regulatory strategy. This is not a document-processing role — it requires the ability to engage with development science, identify potential issues, and contribute informed regulatory thinking rather than just administrative submission support.

**Responsibilities**

-   Develop a working technical understanding of assigned products — formulation composition and rationale, manufacturing process, and analytical/impurity profile — sufficient to identify regulatory implications independently.
-   Review R&D and Analytical data, including formulation trials, stability studies, method validation and characterization data, critically to spot gaps, inconsistencies or risks.
-   Support the Manager/Director in framing regulatory strategy by contributing well-reasoned technical inputs.
-   Assess the regulatory impact of significant development changes and ensure that comparability, bridging or additional evidence requirements are addressed prospectively.
-   Prepare and/or review assigned dossier sections, briefing packages and responses to major authority questions, ensuring completeness.
-   Drive submission readiness, including gap closure, review cycles, issue escalation and completion against agreed milestones.

## Requirements

**Experience and Qualifications**

-   Minimum 4 years of relevant pharmaceutical or biopharmaceutical industry experience.
-   Minimum 2–3 years of genuine exposure in R&D, either formulation development and/or analytical sciences.

**Required Skills**

-   Understanding of and hands-on experience with regulatory dossier structure and requirements, including CTD/eCTD, is preferred, though the primary emphasis of this role is technical/scientific understanding over document compilation.
-   Strong analytical thinking and the confidence to raise technical concerns proactively.
-   Clear written and verbal communication skills for cross-functional technical discussions.
-   Ability to manage multiple deliverables independently within defined timelines.

**Added Advantage**

-   Experience with complex injectables, biologics/biosimilars, drug-device combination products or other technically complex dosage forms.

## Benefits

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