Regulatory Affairs Senior Associate (Pre - Approval) - DEMO Global Services
- Location
- Hyderabad, Telangana, India
- Work mode
- On-site
- Employment type
- Full-time
About the job
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 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.
• 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.
- 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.
• 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.
From Demo S.A.'s careers page (Workable), checked 7 Nov 2026.
How to apply
- Select Apply on apply.workable.com. It opens Demo S.A.'s own application form in a new tab, run on Workable.
- Fill in the form and upload your résumé there. Jobiwork never sees your application.
- Demo S.A. will reply to you directly. No real employer asks you for money to apply.
Posted 6 Nov 2026 · checked 7 Nov 2026 · Report this job
