DS
Hiring companyDEMO S.A.
Verified today
Regulatory Affairs Senior Associate, Pre-Approval
Hyderabad, Telangana, India Full-time On-site
About the role
Regulatory Affairs team at DEMO Global Services ensures product compliance by bridging R&D and regulatory functions. The Senior Associate develops deep technical knowledge of formulation and analytical profiles, reviews data to identify regulatory implications, and supports strategy formulation with technical inputs. Hyderabad, Telangana, India, on-site work model.
What you’ll do
- Develop technical understanding of assigned products
- Review R&D and analytical data to spot gaps and risks
- Support regulatory strategy with technical inputs
- Assess impact of development changes on regulatory requirements
- Prepare and review dossier sections and briefing packages
- Drive submission readiness and manage review cycles
What you’ll bring
- 4+ years pharmaceutical/biopharma experience
- 2-3 years R&D exposure in formulation or analytical sciences
Nice to have
- Hands‑on experience with regulatory dossier structure (CTD/eCTD)
- Strong analytical thinking and proactive issue identification
- Excellent written and verbal communication
- Ability to manage multiple deliverables independently
Skills
Regulatory affairsFormulation scienceAnalytical sciencesDossier managementTechnical writingCross‑functional communication
Benefits
- Competitive salary
- Continuous specialized training
- Career development opportunities
- Friendly working environment