Amneal Pharma Hiring Regulatory Labelling Executive

M.Pharm/B.Pharm/B.Sc Candidates Apply: Amneal Pharma Hiring for Regulatory Labelling Executive in Ahmedabad

Amneal Pharma is hiring Executive/Sr. Executive – Global Regulatory Labelling in Ahmedabad. Open to M.Sc, M.Pharm, B.Pharm, B.Sc. Apply before 21st June 2025.

Executive/Sr. Executive – Global Regulatory Labelling Job Opening at Amneal Pharma, Ahmedabad

Are you a life sciences graduate with experience or interest in global regulatory affairs? Amneal Pharmaceuticals is inviting applications for the position of Executive/Sr. Executive in Global Regulatory Labelling at its Ahmedabad facility. This opportunity is ideal for candidates from M.Sc, M.Pharm, B.Pharm, or B.Sc backgrounds, especially those looking to excel in the pharmaceutical regulatory space.

Key Responsibilities

Regulatory Labelling and Documentation

• Compile and perform the initial review of labeling documents for OSD (Oral Solid Dosage) and Injectable formulations.
• Coordinate with cross-functional teams (CFTs) to track priorities and ensure timely document collection for submissions.
• Maintain updated knowledge of regulatory guidelines and practices in labelling.

Regulatory Response Management

• Prepare and compile deficiency and query responses related to US labeling for OSD and Injectable forms.
• Ensure timely submission of CR (Complete Response), IR (Information Request), and DRL (Deficiency Response Letter) modules.

Product Launch & Site Transfers

• Ensure launch readiness with accurate, updated labeling and approved Ok-To-Print documents.
• Manage timely labeling document preparation for site transfer and additional site activities.
• Support third-party labelling introductions.

Compliance & Change Management

• Monitor and initiate labeling changes through Change Control and Labeling Review Committee (LRC).
• Create Barcode Grade reports and address annual reportable changes, including updates for RLD (Reference Listed Drug) and safety labeling.

Qualifications Required

Candidates must hold any of the following qualifications:

• M.Sc. – Master of Science in Life Sciences
• M.Pharm. – Master of Pharmacy
• B.Pharm. – Bachelor of Pharmacy
• B.Sc. – Bachelor of Science (Life Sciences, Biology, or related field)

Skills and Competencies

• Knowledge of USFDA and international regulatory labelling requirements.
• Familiarity with labeling templates, RLD updates, and drug listing procedures.
• Experience in managing regulatory submissions and coordinating with internal departments.
• Ability to work with tight deadlines and multiple product lines.
• Excellent communication and documentation skills.

Work Location

Address: 901-911, 9th Floor, Ahmedabad City, Gujarat, 380051, India

Job Schedule: Full-time

Last Date to Apply: 21st June 2025

Call to Action

If you meet the qualification and experience criteria, don’t miss this opportunity to join a reputed pharmaceutical company. Apply Now before the deadline!

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