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🌟 Join a Global Leader in Generic Pharmaceuticals! 🌟
Amneal Pharmaceuticals, a high-quality producer of solid and injectable generic products, is rapidly expanding its operations in India. With a focus on relentless quality, integrity, and respect, Amneal is committed to delivering affordable, high-quality medicines worldwide. We’re now looking for talented professionals to join our Regulatory Affairs, Analytical Development, and Formulation teams in Ahmedabad.
Key Points:
- Regulatory Affairs roles available across Pre-Approval/Post-Approval, DMF Review, Labeling, and Clinical for the US, EU, and other markets.
- Positions from Executive to Senior Manager, with 3-15 years of experience.
- Exciting opportunities in Injectable product development and API DMF writing, among others.
- Openings also in Analytical Development and Formulation for Injectable products.
- Apply by sending your latest CV to: kavitriy@amneal.com
Regulatory Affairs – Pre-Approval/Post-Approval | Injectable | US Market
Experience: 3-10 Years | Designation: Executive/Sr. Executive/Assistant Manager/Deputy Manager
This role is crucial for handling submissions related to Injectable products in the US market. You’ll be responsible for developing regulatory strategies, liaising with FDA, and ensuring timely approvals. If you have experience with product development for complex injectables, ophthalmics, and 505(b)2 submissions, this is your chance to shine! You’ll also provide regulatory support for product launches and GMP inspections, ensuring smooth market entry.
Regulatory Affairs – DMF Review | API | US Market
Experience: 4-10 Years | Designation: Senior Executive/Assistant Manager/Deputy Manager
In this role, you will review and prepare API DMFs, particularly focusing on Nitrosamine risk assessment and CCF evaluation. If you have strong technical knowledge in synthetic chemistry, analytical methods, and API DMFs for peptides, this position is perfect for you. You’ll work on nitrosamine assessments and module preparation for the US, Canada, and EU markets, helping drive global projects.
Regulatory Affairs – Labelling (Reviewer) | US & International Market
Experience: 3-10 Years | Designation: Executive/Sr. Executive/Assistant Manager/Deputy Manager
For those with expertise in labeling regulations for oral solid dosage forms (OSD) and injectables, this role offers the opportunity to review and compile labeling documents for ANDA submissions. You’ll work with cross-functional teams to ensure that all labeling modules are submitted on time and in compliance with current regulatory guidelines. Your ability to handle deficiency responses will ensure a smooth approval process.
Regulatory Affairs – Clinical | US Market
Experience: 8-15 Years | Designation: Manager/Sr. Manager
Lead a team focused on managing ANDA BE (Bioequivalence) activities and regulatory filings. This role is ideal for those experienced in tracking regulatory activities, archiving, and managing databases. You’ll be responsible for regulatory submissions, ensuring that all ANDA filings and clinical submissions are on track, from initial development to approval.
Analytical Development – Injectable | Method Development
Experience: 3-7 Years | Designation: Executive/Sr. Executive
Join the team responsible for developing methods for injectable products. Using advanced instruments like HPLC, IC, and GC, you will handle method development, validation, and stability analysis for new injectable products. This role will give you hands-on experience with method transfer activities and COA preparation for development batches.
Formulation & Development – Injectable | USA, EU & Domestic Market
Experience: 4-10 Years | Designation: Senior Executive/Assistant Manager
If you’re skilled in injectable formulation development, this role is for you! You’ll work on the development of complex injectables such as emulsions and colloidal solutions, preparing key documents like MFR and stability protocols. Experience with QbD principles and knowledge of API, excipients, and finished product specifications will be advantageous.
Technology Transfer – Formulation & Development | Injectable
Experience: 3-7 Years | Designation: Senior Officer/Executive/Sr. Executive
This role involves preparing Master BMR and BPRs while coordinating with departments like QA, QC, and manufacturing for the successful execution of scale-up and exhibit batches. You’ll study critical process parameters, log change controls, and ensure readiness for batch execution. Strong organizational skills and attention to detail will make you a key player in this process.
Development QA – Research & Development | Injectable
Experience: 3-7 Years | Designation: Senior Officer/Executive/Sr. Executive
In this role, you will oversee quality assurance activities during product development, focusing on stability studies, document management, and SOP preparation. You’ll also play a key role in training new employees and ensuring that quality standards are met across all R&D projects.
How to Apply:
Interested candidates are invited to send their CVs to kavitriy@amneal.com. This is a fantastic opportunity to join one of the fastest-growing global generic pharmaceutical companies and contribute to life-saving medicine development. Don’t miss out! 🌍💊