Regulatory affairs

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.

Strong knowledge of country-specific labeling regulations and guidelines across the US, EU, Canada, Australia, and Switzerland, combined with hands-on experience in label development, including CCDS, USPI, and packaging components. 

The Manager, Regulatory Affairs – CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products.

MPharm / MSc / BPharm / BSc. Unichem Laboratories Ltd. is one of Indias most respected pharmaceutical companies committed to deliver better health through superior products.

Keeping individual updated for all current regulatory trend and providing regulatory science awareness at organization level. Expertise in providing Regulatory strategic solutions based on experience with different regulated Agencies to come out of box thinking.