Senior Executive, Regulatory Affairs

Amneal Pharmaceuticals is seeking a detail-oriented and proactive Senior Executive – Regulatory Affairs to support regulatory submissions, lifecycle management, and compliance activities across global markets. The involves preparing and reviewing dossiers, coordinating with cross-functional teams, and ensuring timely and accurate submissions in line with international regulatory standards. The candidate will play a key in supporting market expansion initiatives, managing post-approval changes, and addressing health authority queries while ensuring adherence to evolving regulatory requirements.

Roles & Responsibilities

• Prepare, review, and submit CTD, ACTD, and country-specific dossiers for new product registrations.
• Handle submissions for line extensions including strength, pack size, and shelf-life changes.
• Manage regulatory submissions for variations, renewals, and re-registrations.
• Coordinate compilation of Modules 1–5 with QA, QC, R&D, CMC, Pharmacovigilance (PV), Product Management (PM), and Manufacturing teams.
• Ensure all submissions comply with WHO, ICH, and country-specific regulatory guidelines.
• Support regulatory strategy by providing feasibility assessments and timelines for new products and markets.
• Evaluate regulatory impact of formulation changes, process updates, and site transfers.
• Manage lifecycle activities including CMC variations, labeling updates, and artwork revisions.
• Track submission timelines and ensure timely approvals and renewals.
• Maintain accurate and up-to-date regulatory documentation and databases.
• Handle deficiency letters and queries received from regulatory authorities.
• Prepare and submit responses to health authority queries in coordination with internal stakeholders.
• Liaise with local agents, consultants, and partners for RoW market submissions when required.
• Monitor updates in regulatory guidelines and ensure compliance with the latest requirements.
• Support internal audits and ensure readiness for regulatory inspections.
• Maintain proper documentation control and version management of regulatory documents.
• Ensure compliance with company policies, regulatory standards, and quality systems.
• Collaborate with cross-functional teams for smooth execution of regulatory activities.
• entify potential regulatory risks and escalate issues proactively.
• Support continuous improvement initiatives in regulatory processes and documentation practices.

Amneal Pharmaceuticals is a global pharmaceutical company focused on developing, manufacturing, and distributing a broad range of high-quality medicines. The company serves patients worldwide with a strong commitment to accessibility, innovation, and affordability.

Our Story

Amneal Pharmaceuticals was established with a vision to make essential medicines more accessible to patients across the globe. Over the years, the company has grown into a diversified pharmaceutical organization with a strong presence in multiple markets.

By combining scientific expertise with operational excellence, Amneal continues to expand its portfolio and global footprint.

Our Mission

• To provide high-quality and affordable medicines
• To improve patient access to essential healthcare solutions
• To drive innovation across pharmaceutical segments
• To maintain strong standards of quality and compliance

Our Vision

To be a leading global pharmaceutical company delivering accessible and innovative healthcare solutions.

Our Services / What We Offer

Amneal Pharmaceuticals offers a wide range of pharmaceutical solutions:

• Development and manufacturing of generic medicines
• Specialty pharmaceutical products
• Injectable and complex dosage formulations
• Global distribution of healthcare products

Why Choose Us

• Strong global presence across multiple markets
• Diverse portfolio of pharmaceutical products
• Focus on affordability and accessibility
• Advanced manufacturing and R&D capabilities
• Commitment to quality and compliance

Our Team

Amneal is supported by a global team of professionals, including scientists, researchers, and healthcare experts dedicated to delivering high-quality pharmaceutical solutions.

Infrastructure / Technology

The company operates advanced manufacturing facilities and research centers equipped with modern technologies to support innovation, efficiency, and quality assurance.

Our Commitment

Amneal Pharmaceuticals is committed to improving patient health by delivering safe, effective, and affordable medicines. The company focuses on innovation, operational excellence, and meeting global healthcare needs.