Job Information
Abbott Emerging Markets Regulatory Manager in Mumbai, India
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 R equ ired
Education: Chemistry, Pharmacy.
Years of Experience: at least 7 years in Regulatory Affairs & RA compliance, data analysis, project Management …
Language: Fluent English
Location:India Mumbai
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com