Regulatory affairs

Degree in a Life Science or a related discipline, preferably MSc. Experience in preparation and management of regulatory documentation, normally a full international submission new product application or large variations.

First level manager of a work team that may comprise professionals, technical and/or administrative staff. Typically without budget or hire/fire authority.

Hire an Associate Regulatory Affairs to support our North America business. This role will be based in person in Hyderabad and is an 8-month temporary assignment to provide maternity leave coverage.

Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames and submissions.

Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Sterile dosage form / complex injectable dosage form and brief manufacturing process and key regulatory aspects. Amneal Pharmaceuticals. Qualification : B.Pharm, M.Pharm

This role serves as a key contributor to regulatory operations by ensuring the accuracy, integrity, and compliance of regulatory information used for global submissions, registrations, product maintenance, and post-market activities.

Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development

Post Graduate Degree from a recognized University under Pharmacy / Regulatory affairs / Biomedical science / Medical device / Biomedical technology or equivalent Or Graduation in Biomedical Engineering. Indian Pharmacopoeia Commission

Lead cross-functional regulatory discussions, align stakeholders on submission strategy, and communicate regulatory implications to support business and product development decisions.