Emerging Markets Regulatory Manager

2 months ago


Mumbai, India Abbott Laboratories Full time

Duties & Responsibilities

Project Management:

  • Support Regulatory projects and Compliance standpoint on key projects within EM Regulatory groups
  • Management End to End key RA project: acting as project manager & connecting point among key EPD stakeholders within & out of Regulatory groups such as EM Commercial affiliates (Quality & Regulatory functions
  • Prepare powerpoints &  Executive presentations for monthly reporting to Senior Leadership Team
  • Effective communication & interpersonal skills with the ability to collaborate with cross functional teams and convey compliance concepts to non technical stakeholders
  • Ability to work collaboratively within a team enviremnment, prioritize tasks & assist in managing multiple project simultaneoustly

Data analytics:

  • Solid analytical skills with the ability to comprehend & apply regulatory requirements to operational processes
  • Perform extensive data analysis,  generates weekly, monthly reports & trends
  • Preparing RA reports for all regulatory activities (New registrations, renewals, LCM)
  • Monitor timely RA submission & approvals & report all the significant events& changes in the regulatory environment

Maintain an up-to-date database for all submissions

Compliance:

  • Issuing and updating the SOP in line with Global SOP and Local Regulation in EM countries.
  • Guarantee the compliance with national legislation, international regulatory guidelines and internal requirements.
  • Ensure that the End to End compliance management process is in compliance with the local regulation and global SOP..
  • Support / execute Audit preparation, Non conformance report and validation CAPA plans
  • Assure Record Management plan for all Regulatory documentation
  • Proven track record of developing 7 implementing compliance program procedures
  • In depth knowledge of regulatory requirements

Experience Required

  • Education: Chemistry, Pharmacy.
  • Years of Experience: at least 7 years in Regulatory Affairs & RA compliance, data analysis, project Management â¦
  • Language: Fluent English
  • Location:India Mumbai


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