Regulatory affairs

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.

H & H Healthcare and Cosmetics Pvt. Ltd. is involved in the manufacturing and supplying of  Nutraceutical, Pharmaceuticals, Syringe, Injection, Herbal and Cosmetics products.

Injectable and Complex Injectable experience for Pre Approval Team for US Market is mandatory. Injectable and complex Injectable experience is must.

Responsible for planning, coordinating, and executing manufacturing operations, including commissioning, qualification, and documentation as per cGMP.

Graduate or preferably Postgraduate in Sciences/ Life Sciences/ Pharmacy/ Biomedical/ Engineering. Draft, review, submission and archival of Regulatory filings (Re-registrations / New Registrations / Legal- Physical manufacturer transfer) for India market under guidance and instructions of RA Leads/ Supervisor.