Pharm'Up 
Amneal Pharmaceuticals is inviting applications for the position of Senior Executive, Clinical Affairs to support global clinical operations for its New Chemical Entity (NCE) development programs in Ahmedabad. The role combines clinical trial administration, Trial Master File (TMF) oversight, regulatory submission management, and integration of AI/ML-driven trial tracking solutions.
Position Summary
- Designation: Senior Executive, Clinical Affairs
- Location: Ahmedabad City, Gujarat
- Functional Area: Clinical Affairs / Clinical Operations
- Industry Type: Pharmaceuticals / Healthcare / Clinical Research
- Application Deadline: October 30, 2026
Key Responsibilities
- Trial Operations & Milestone Tracking: Deliver administrative and operational oversight for Phase 1–4 global clinical trials; monitor patient recruitment, site initiation, and study close-out progress.
- TMF & Essential Documentation: Maintain Trial Master Files (TMF) ensuring quality control and strict adherence to ICH-GCP Section 8 guidelines.
- Regulatory Submissions: Prepare and submit regulatory and ethics committee documentation packages (IND, CTA, amendments, and annual reports); track agency correspondence across regions with a focus on FDA standards.
- Study & Safety Documentation: Assist in drafting study manuals, monitoring plans, protocol amendments, Investigator’s Brochures (IB), Informed Consent Forms (ICF), and coordination of safety packages (SUSARs, DSURs, PSURs).
- Vendor & Site Coordination: Oversee correspondence and documentation tracking with clinical sites, CROs, central laboratories, imaging vendors, and ePRO/eCOA partners.
- Digital & AI Innovation: Work with internal and external collaborators to implement AI/ML tools, automated trial tracking dashboards, and modern data workflows in clinical operations.
- Audit Readiness: Coordinate and participate in TMF audits, CRO inspections, and regulatory health authority reviews (FDA, EMA, CDSCO).
Eligibility & Qualifications
- Experience: Minimum 6+ years of relevant experience in pharmaceutical or regulatory affairs domains.
- Education:
- Required: Bachelor’s degree (B.Sc. / B.S. / B.Pharm) in a Science field.
- Preferred: Master’s degree (M.Sc. / M.S. / M.Pharm) in a Science discipline.
- Core Competencies:
- Hands-on experience developing FDA submission dossiers and understanding global regulatory guidelines.
- Practical knowledge of CTMS, EDC, and electronic TMF platforms.
- Familiarity with GCP principles, risk management, and clinical trial lifecycle operations.
About the Author
