Hetero Labs Limited – Urgent Openings for Regulatory Affairs – Formulation / API Executive/Sr. Executive
Hetero Labs Limited is a globally renowned vertically integrated pharmaceutical player engaged in research and development, manufacturing, and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas. Backed by 27+ years of expertise in the pharmaceutical industry, Hetero’s strategic business areas spread across APIs, Global Generics, Biosimilars and Custom Pharmaceutical Services. The company is among the largest producers of Active Pharmaceutical Ingredients (APIs) in the world.
URGENT OPENINGS FOR REGULATORY AFFAIRS-FORMULATION/API-HYDERBAD
Department: Regulatory Affairs/Formulation/API
Designation: Executive/Sr. Executive
Experience: 2 to 8 years
Industry: Pharma Industry(Mandatory)
Well versed with the concepts of pharmaceutical analysis, regulatory trials, laboratory testing of drugs, good manufacturing practices etc.
Regulatory Documentation, Dossier preparation in e-CTD/ CTD/ ZACTD format, handling documentation related to MOH Drug Registration, Regulatory strategy, responding to queries of health authorities, Pharmaceutical product registration
Strong background in providing responses to regulatory agencies regarding product information or issues
Keen communicator with honed problem solving and analytical abilities
Coordinating with Quality Assurance, Quality Control, Formulation, Research & Development departments as well as reviewing the technical documents as per the guideline or checklist for preparation of dossier in CTD format
Carrying out periodic self-inspection for proper dossier preparation as per the updated registration guideline to improve efficiency / compliance
Desired Candidates Please Share Your Updated Resume At firstname.lastname@example.org