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 workplace.

📌 Regulatory Affairs Senior Associate (Pre - Approval) - DEMO Global Services (India)
🏢 Demo
📍 India