Regulatory Affairs Specialist Job

Regulatory Affairs Specialist to perform the following duties:

• Serves as the sponsor administrative professional for completion or coordination of all submissions made to US-FDA/CVM using CVM eSubmitter.
• Author and/or collaborates to develop SOPs – designing a system that works internally at Cronus Pharma, coincides and complements Cronus Specialties, India.
• Review, complete and submit all annual antimicrobial reporting, DERs, MCSR, and Facility Registrations, etc.
• Review and coordinates development and revisions of labels and marketing materials for submissions to CVM
• Supports CMC activities in reference label and FOI review, green book patent and exclusivity review, trade name selection/filing activities, and FDA databases for product relevant information.
• Collaborate and support regulatory team with PV contractor and manufacturing partners for resolution of product complaints and perform periodic audits of pharmacovigilance cases.
• CMC and GLP submission review for accuracy, quality, and completeness per regulatory requirements.
• Coordinate and draft agendas, compile data and supporting information for meeting requests with CVM.
• Support regulatory department and management in product and regulatory strategy research.

Bachelor’s Degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science or Pharmaceutics