DRA

B.Pharm or Graduation in Biomedical Sciences. Minimum 3 years experience for Operations Manager and 1 year experience for Associate Manager in pharmaceutical / medical device regulatory affairs.

Establish strong relationship with country regulatory authorities to facilitate technical and strategic discussions related to product. Baxter

Prepare regulatory dossiers and technical documentation for IVD products. Draft SOPs, validation protocols, stability study protocols, and performance study protocols.

To co-ordinate with Cross Functional Team for getting various documents required for filing the product in India. Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.

Manage product registrations, renewals, variations and lifecycle activities. Review SmPC, PIL, artworks, labels and other regulatory documents.

Master Degree in Pharmacy / Forensic Pharmacy with specialization in Pharmacology or concerned/allied/relevant discipline with a very good academic record throughout. two publications in renowned journals of repute UGC -care listed journal/ Web of Science /SCOPUS Indexed journals

Experience into solid oral dosage & liquid orals form in Formulation and development department for regulated market

Scheduling the life cycle management activities globally for all the regulatory submissions complying with region specific requirements.

Knowledge of Injectable plant in Validation of injection filing line, Lyo, Autoclave, DHS etc & Knowledge of QMS