Regulatory affairs

Solid Oral Formulation Development, QbD, Scale-Up, Pilot Batches & Tech Transfer. Literature Review & Excipient Compatibility.

Responsible for executing technology transfer activities for injectable dosage forms, including planning and performing Scale-up, Exhibit and Process Validation batches with optimal utilization of manpower, materials, and equipment.

Masters in Pharmacy or Masters in Science / Life Sciences. College or University degree or equivalent work experience that provide knowledge of and exposure to fundamental theories, principles and concepts.

Bachelors degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry. Genpact

Dossier Preparation in CTD/ACTD/eCTD/National format. Must have Parenteral and partially OSD dosage forms exposure.

Adequate understanding on respective authority guidance and filing of new product and post approval changes. Review of documents related to product registration and dossier submission leading to faster approval

Responsible for executing technology transfer activities for injectable dosage forms, including planning and performing Scale-up, Exhibit and Process Validation batches with optimal utilization of manpower, materials, and equipment.

HOF PHARMA IS HIRING FOR FORMULATION MANUFACTURING FACILITY BASED AT SANAND, GUJARAT

Lead regulatory submissions for Inhalation, Nasal, Oral Solid Dosage, Contract Manufacturing, and Strategic Alliance projects for the US market.