Pharma Regulatory Executive

3 weeks ago


Nimrana RJ IN Forty7 Interior Architect Full time

Responsibilities Ensure product compliance with all relevant standards and regulations Developing and executing global regulatory strategies for drug development and product lifecycle management Leading regulatory submissions such as INDs Investigational New Drug applications NDAs New Drug Applications MAAs Marketing Authorization Applications and post-marketing variations Interfacing with regulatory authorities to negotiate and resolve issues facilitate approvals and maintain compliance Monitoring changes in regulatory requirements and ensuring internal processes and documentation are updated accordingly Managing regulatory teams and collaborating with cross-functional departments including R D Clinical Quality and Legal Qualifications Advanced degrees in life sciences pharmacy or related fields e g PharmD PhD MSc Extensive experience in regulatory affairs including strategic and operational roles Strong knowledge of global regulatory frameworks FDA EMA ICH guidelines etc Job Type Permanent Pay 15 000 00 - 40 000 00 per month Benefits Food provided Health insurance Paid sick time Work Location In person



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