Company Jobs

To plan and execute various development trials for the allocated project in formulation laboratory along with online recording of experiments and data compilation. To carry out stability studies of projects as per the project requirement and regulatory guidelines.

Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach.

Provides inputs for selection of the equipment Estimates the batch size based on available equipment at the receiving site. Assists in evaluating the suitability of partners development, manufacturing facility for technology transfer.

Experience in oral solid dosage Manufacturing, CVC Packaging. Exposure to Granulation, Compressioa Cooting and Bottle Packaging.

Responsible to monitors activities at clinical study sites to assure adherence to Good Clinical Practices GCPs, Standard Operating Procedures, and study protocols under supervision of Clinical Operations Manager, Clinical Research Specialist.

Compilation and review of product license applications, variations, and renewals for Mexico or ASEAN countries as per regulatory requirements respectively with minimal supervision. Manages electronic documents and creates electronic submissions in CTD format.

End to end case management, including case receipt, database entry, peer review and submission to applicable regulatory authorities within stipulated time. Perform and monitor literature for company molecules.

Granulation, Compression, FBE, Cyto, Sex Hormones Blister Packing - Primary, Capsule Hard Gelatine and Soft Gelatine.

Biophore, an established pharmaceutical company, is engaged in the development and manufacturing of niche pharmaceutical products for the generic industry. Within a decade since inception in 2007, Biophore has emerged as a trusted partner in the generic industry across US, Europe and other regulated markets.