Regulatory Affairs Senior Associate (Pre - Approval) - DEMO Global Services
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Before you apply
LocationHyderabad, Telangana, India
Typefull-time
SenioritySenior
Experience4+ yrs
DepartmentRegulatory Affairs
Company size501–1,000 people
PostedNov 6, 2026 · 2d ago
Verified live1d ago
At a glanceSummarised by Seekless from the posting.
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
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
Understanding of and hands-on experience with regulatory dossier structure and requirements, including CTD/eCTD
Experience with complex injectables, biologics/biosimilars, drug-device combination products or other technically complex dosage forms
Skills
CTD
eCTD
About the role
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
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Develop a working technical understanding of assigned products — formulation composition and rationale, manufacturing process, and analytical/impurity profile — sufficient to identify regulatory implications independently.
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Review R&D and Analytical data, including formulation trials, stability studies, method validation and characterization data, critically to spot gaps, inconsistencies or risks.
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Support the Manager/Director in framing regulatory strategy by contributing well-reasoned technical inputs.
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Assess the regulatory impact of significant development changes and ensure that comparability, bridging or additional evidence requirements are addressed prospectively.
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Prepare and/or review assigned dossier sections, briefing packages and responses to major authority questions, ensuring completeness.
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Drive submission readiness, including gap closure, review cycles, issue escalation and completion against agreed milestones.
Requirements
Experience and Qualifications
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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
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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
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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.