Amneal Pharmaceuticals Hiring Global Toxicology & Nonclinical Development – Assistant Manager, Deputy Manager, Manager

Amneal Pharmaceuticals Hiring Global Toxicology & Nonclinical Development

Amneal Pharmaceuticals, a global leader in the pharmaceutical industry, is seeking qualified candidates for the roles of Assistant Manager, Deputy Manager, and Manager in Global Toxicology & Nonclinical Development. These positions are based in Ahmedabad, Gujarat, and offer an excellent opportunity to join a dynamic team dedicated to advancing healthcare through innovative and high-quality medicines.

About Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a global pharmaceutical company with a robust portfolio of over 270 high-quality medicines. With a team of more than 7,500 colleagues, Amneal is committed to making healthy possible through the development, manufacturing, and distribution of its diverse product range.

Job Role and Responsibilities

Global Toxicology & Nonclinical Development

Positions Available:

• Assistant Manager
• Deputy Manager
• Manager

Location:

• Corporate Office, Ahmedabad, Gujarat

Responsibilities:

• Design, conduct, and interpret nonclinical studies.
• Manage outsourcing to Contract Research Organizations (CROs).
• Oversee regulatory nonclinical studies for generics (505b2 NDA requirements).
• Conduct impurity qualification as per ICH guidelines.
• Perform toxicology risk assessments of drugs, impurities, and excipients.
• Evaluate leachable and extractable toxicological risks.
• Conduct genotoxicity assessments of drugs/chemicals/impurities and determine PDE/OEL.
• Address queries from regulatory agencies.
• Involved in the execution and audit of non-clinical studies.

Key Qualifications

To be eligible for these roles, candidates must meet the following qualifications:

• Educational Background: BVSc, MVSC, M.Pharm, MSc, and/or PhD in toxicology.
• Experience: 7-12 years in nonclinical studies, toxicology risk assessments, and regulatory submissions.

Skills Required

• Strong understanding of nonclinical studies and toxicology.
• Expertise in regulatory nonclinical study requirements.
• Proficiency in impurity qualification, toxicology risk assessment, and genotoxicity evaluation.
• Ability to address regulatory queries and manage non-clinical study execution.

How to Apply

Interested candidates are invited to share their CVs at Kavitriy@amneal.com

Important Note

Please beware of fake job offers claiming to be from Amneal Pharmaceuticals. Amneal does not send job offers from free email services such as Gmail, Rediffmail, Yahoo Mail, Hotmail, etc., nor does it charge any fees or security deposits from job seekers. Any suspicious activity should be reported to Amneal directly.