Job Title: Logistics Executive & Regulatory Affairs Professionals (US Market)
Company: Alembic Pharmaceuticals
Location: Vadodara, Gujarat, India
About Alembic Pharmaceuticals:
Alembic Pharmaceuticals, a leading integrated pharmaceutical company, is expanding its teams in Vadodara. We deliver high-quality, affordable healthcare solutions globally and are seeking talented individuals for key roles in Logistics and Regulatory Affairs.
1. Logistics Executive
We seek a Logistics Executive to manage crucial export operations, ensuring smooth and compliant product flow.
Key Responsibilities:
- Handle shipping bills and all export documentation.
- Verify checklists and secure necessary approvals.
- Coordinate with Custom House Agents (CHA), freight forwarders, and shipping lines.
- Manage customs clearance and shipment documentation.
- Facilitate internal coordination across Sales, Production, Warehouse, and Finance.
- Maintain accurate shipment records and provide timely updates.
Required Qualifications & Experience:
- Graduate in Commerce, Logistics, Supply Chain, or a related field.
- 2-5 years of experience in export logistics and documentation.
- Proficient knowledge of shipping bills, customs procedures, and export documentation.
- Essential SAP system experience.
- Strong communication, coordination, and MS Excel skills.
2. Assistant Manager / Deputy Manager – Regulatory Affairs (US Market, Non-Oral)
We seek a highly motivated Regulatory Affairs professional for US regulatory activities, focusing on Non-Oral (Sterile) dosage forms and comprehensive post-approval lifecycle management.
Key Responsibilities:
- Support US regulatory activities for Non-Oral dosage forms, especially Sterile products.
- Manage post-approval regulatory submissions and lifecycle management.
- Ensure full compliance with USFDA requirements through cross-functional coordination.
- Prepare and submit PAS, CBE-30, CBE-0, Annual Reports, and other post-approval filings.
Required Qualifications & Experience:
- B.Pharm, M.Pharm, M.Sc., or an equivalent qualification.
- 7-12 years of Regulatory Affairs experience in the pharmaceutical industry.
- Mandatory hands-on experience in US Market Regulatory Affairs and Post-Approval/Life Cycle Management.
- In-depth knowledge of USFDA regulations, CFR requirements, and guidance documents.
- Experience with Electronic Submission Management and eCTD publishing/submission processes.
- Familiarity with regulatory software/tools.
Join Us:
Join a dynamic team at Alembic Pharmaceuticals, where innovation and quality drive global healthcare. We offer a challenging yet supportive environment for professional growth and expertise development.
Application Process:
If you meet the qualifications for these roles, please submit your detailed resume.
