Emerging Markets Regulatory Manager
2 months ago
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 & Â 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, Â 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
- 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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