Amneal Pharma Hiring Regulatory Labelling Executive

M.Pharm/B Pharm/BSc 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 MSc, M.Pharm, B Pharm, BSc. 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 MSc, M.Pharm, B Pharm, or BSc 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:

• MSc. – Master of Science in Life Sciences
• M.Pharm. – Master of Pharmacy
• B Pharm. – Bachelor of Pharmacy
• BSc. – 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!

Summary Table

Company Name	Amneal Pharmaceuticals
Vacancies	Global Regulatory Labelling (Executive/Sr. Executive)
Required Education	MSc, M.Pharm, B Pharm, BSc
Experience	2–6 years preferred, freshers with strong skillsets may apply
Location	Ahmedabad, Gujarat