The Regulatory Affairs Manager (Pre- Approval) will lead regulatory strategy and submission readiness for assigned development products from early development through first approval. The role integrates product, formulation, process, analytical, stability, nonclinical, clinical and device information, as applicable, to identify regulatory risks, influence development decisions and establish scientifically defensible regulatory positions. The Manager will combine strategic scientific judgement with disciplined dossier planning, review and submission execution.

Responsibilities

Develop and maintain product-specific regulatory development plans covering legal basis or pathway, target markets, reference product strategy and authority engagement
Provide early regulatory input into formulation selection, process parameters, control strategy, analytical method development, stability plans, study designs and device development activities, as applicable
Translate product and development science into explicit regulatory positions, including the rationale, assumptions, gaps,



risks and proposed mitigations
Identify emerging, non-obvious or insufficiently addressed regulatory and technical risks early and recommend alternative strategies to mitigate risks
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 and defensibility
Drive submission readiness, including gap closure, review cycles, issue escalation and completion against agreed milestones

Requirements

Experience and Qualifications

Minimum 8 years of relevant pharmaceutical or biopharmaceutical industry experience
Minimum 6 years of hands-on Regulatory Affairs experience
Minimum 3 years of direct experience in development or pre-approval regulatory strategy, major submissions,

📌 Regulatory Affairs Manager (Hyderabad)
🏢 DEMO Pharmaceuticals
📍 Hyderabad