Kashiv US

Assistant Manager, Regulatory Affairs

Good knowledge of US ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Solid oral dosage form/Liquid Oral/Transdermal dosage form / topical-Inhalation dosage…

Assistant Manager, Regulatory Affairs

Regulatory Compliance Version Control

Description: Responsible for managing regulatory affairs activities and regulatory strategy execution to ensure compliance with global regulatory requirements, industry standards, and ethical practices throughout…

Executive, Regulatory Affairs

Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. API DMF and DMF Change Notification review with respect to USFDA regulatory requirement. Exposure of the…

Assistant Manager, Regulatory Affairs

On-siteAPAC

AI Risk Assessment Technical Writing

Preferred Qualification: M. Pharm. Preferred Experience: 8-12 yrs (for AM/DM level) Job Description: Preparation, scientific review, coordination & finalization of ANDA/NDA CMC modules for oral solid, oral liquid,…

last month

Senior Executive, Regulatory Affairs

APACSenior

Key Responsibilities Compile, prepare, review, and submit high-quality US ANDA and EU marketing authorization applications, including original submissions and amendments, for MDI/DPI inhalation products in compliance…

Regulatory Compliance

6 months ago

Deputy Manager, Regulatory Affairs

Prepare, Review and Finalize Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and…