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DG - Lead Associate - Regulatory Affairs

With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us.
Transformation happens here. Come, be a part of our exciting journey!
Inviting applications for the role of Lead Associate, Regulatory affairs.!
 The Submission Analyst is responsible for executing activities around data elements identified as required in the Data Migration Plan or the resulting report.  In addition, will be required to enter data into the target Veeva Vault RIM based on feedback provided by market contacts.

Responsibilities
•    Develop basic reports to obtain as is data for internal review and by the business unit. 
•    Review submission-related data and documents to determine potential matches between submissions
•    Contacts appropriate business units to provide input on as-is data and required corrections to data. 
•    Execute clean-up based on business unit input. Combines submission documents based on business feedback. Inactivates submission records that are no longer required
•    Prepare status reports, final reports, and metrics for remediation activities. 
•    Identify the regulatory submission requirements, based on regulatory guidelines. 
•    Liaise with local country regulatory teams to verify the submission requirements. 
•    Plan the due dates, and coordinate the on-time delivery of the renewal content, to meet regulatory requirements. 
•    Review the submission content for accuracy and completion against the submission requirements. 
•    Peer review of the analyzed submission data.  
Qualifications we seek in you!

Minimum Qualifications
•    Bachelor's degree required in science, engineering or related field 
•    Experience in executing Veeva data migration strategy and cleansing migrated data. Ability to deliver on business commitments and project timelines.

Preferred Qualifications
•    Advanced degree in science, engineering or related field 

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.

 

Job: Lead Associate

Job ID: LIF005867

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Sep 1, 2021

Master Skills List: Operations

Job Category: Full Time