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Job Details

Experience: 10-15 Years | Salary: 18,00,000-24,00,000 | Opening(s): 1 | Posted Date : 2023-02-22
Hiring For Leading MNC
Designation Manager- Regulatory Affairs US
Job Description
  • Act as Subject Matter Expert in Basel Model monitoring domain independently leading projects and working directly with business to deliver high quality output.
  • Ensure Basel model maintenance is in line with Group standards.
  • Work with multiple stakeholders simultaneously and deliver in a timely, efficient and effective manner.
  • Ensure adherence with all the applicable compliance policies (Data security policy, AML, operational risk, Functional manual, Group Compliance Manual, Audit recommendations, Internal Control requirements, regulatory guidelines etc.) and business standards of Organization as applicable. Take timely action on Audit and IMR comments and be able to demonstrate compliance with Internal controls
Desired Profile
  • Result-oriented, accomplished pharmaceutical professional with sound knowledge on current FDA requirements and guideline for ANDA submission, remains up to date with changing guidelines
  • Well versed with database creation and maintenance, MS Excel, PowerPoint
  • Good strategic written and verbal communication and presentation skills
Functional Area Clinical Research
Skills Regulatory affairs , CMC, ANDA
Education Master in Pharmacy (Pharmaceutics / Pharmaceutical Chemistry / Pharmaceutical Analysis)
Location Mumbai
Contact HR
Call on +91-120-358-0000
Reference id 102507