Advance Your Career in Regulatory Strategy for Complex Injectables at Amneal Pharmaceuticals-Apply before 30th May 2025

About Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. is a global, innovation-driven pharmaceutical company dedicated to delivering accessible, high-quality medicines. With a team of over 7,500 professionals worldwide and a portfolio of more than 270 products, Amneal is committed to making healthy possible for millions of patients.

Position Overview

Role: Manager – Regulatory Affairs (Pre-Approval)
Division: Injectable | US Market
Experience: Minimum 10 years in Regulatory Affairs, with 12+ years of total industry experience
Location: Ahmedabad, Gujarat
Application Deadline: 30th May 2025

Key Responsibilities

• Develop and implement regulatory strategies for complex injectable products, including peptides, liposomes, microspheres, nano-suspensions, ophthalmics, otics, topical gels, and 505(b)(2) submissions.

• Prepare and finalize Pre-ANDA/Pre-IND/Scientific Advice meeting packages; coordinate communications with global regulatory agencies (FDA, EMA, Health Canada).

• Draft and review controlled correspondences and deficiency responses for complex and 505(b)(2) products.

• Review in-vitro characterization and sameness reports for APIs and finished products.

• Conduct DMF reviews for complex APIs in accordance with regulatory workflows.

• Collaborate with cross-functional teams including R&D, QA, and manufacturing to ensure compliance and timely submissions.

• Provide guidance and mentorship to team members on evolving regulatory landscapes and complex product filings.

Candidate Profile

• Education: M.Pharm or PhD in Pharmaceutics or Regulatory Affairs

• Experience: At least 10 years in regulatory affairs with hands-on expertise in complex product filings for the US and EU markets

• Deep understanding of the regulatory lifecycle including strategy, submissions, deficiency handling, and compliance

• Demonstrated ability to lead interactions with global health authorities and contribute to cross-functional decision-making

• Strong critical thinking, problem-solving, and communication skills

• Proactive, solution-oriented, and collaborative with a strong sense of accountability

Why Join Amneal?

• Opportunity to work on cutting-edge injectable and complex generics

• Collaborative and innovation-focused work environment

• Exposure to global regulatory frameworks and strategic decision-making

• Commitment to professional growth and continuous learning

📩 Interested candidates are encouraged to apply before 30th May 2025.
Join us at Amneal and be part of a purpose-driven team shaping the future of affordable healthcare.