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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 (Hyderabad)
🏢 DEMO Pharmaceuticals
📍 Hyderabad