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Lead Consultant - 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.
Are you the one we are looking for?
We are inviting applications for the role of Assistant Manager, Regulatory affairs. 
In this role, you will be expected to work on deadlines, in a fairly high pressure business environment while being a good great teammate.
Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.
Responsibilities:
•    Liaise with key interfaces on project requirements to ensure timelines are mutually understood.
•    Drafting responses to MAH for Health Authority queries.
•    Identify discrepancies/issues in local implementation of corporate labels.
•    Lead team for timely deliverables.
•    Monitor reference labels (from up to three countries) for updates and ability to connect with concerned affiliates directly using Sanofi communication/collaboration tools. 
•    Maintaining updates related to labeling guidelines and regulations as they pertain to the development/maintenance of CCDS, US, EU and ROW labeling.
Qualifications we seek in you!
Minimum qualifications
•    Masters in Lifesciences or equivalent with proven experience in regulatory Affairs/Labeling or equivalent 
•    Knowledge of the principles and concepts of Labeling
•    Ability to identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions
•    Must be able to construct a Company Response (MAH response) for health authority questions
Preferred qualifications
•    Excellent communication and PC skills

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 Consultant

Job ID: LIF006573

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Dec 13, 2021

Master Skills List: Operations

Job Category: Full Time