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Lead Associate - Regulatory Affairs

    With a startup spirit and 80,000+ 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.

Inviting applications for the role of a Lead Associate, Regulatory Affairs 
You should have experience in regulatory affairs with knowledge of current regulatory guideline of Global/LATAM Market. 
Expertise in Spanish language translation will be a plus point.
Responsibilities
In this role, you will be responsible for:
GLOBAL LABELING: 
•    Demonstrate knowledge and understanding of CCDS, Global labeling and the dynamics of labeling team.
•    Work over Global CCDS and local HCPI/SmPC for additional local indication comparison. 
•    Work over competitor label analysis 
•    Strong knowledge of key regulatory and labeling principles and SOP’s.
•    Work in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Proficient in presenting to senior management when required. 
•    Proficient in using MS office tools and collaboration software such as VIVA VAULT/ShareDoc etc. 

LATAM MARKET: 
Translation Management:
•    Translation management activities for LATAM countries via SDL software. 
•    Coordination with cross-functional teams for translation management activity.
•    Coordination of translation for maintenance events, renewals, Chemistry Manufacturing & controls (CMC), Company Core Data Sheet (CCDS)
•    Quality check and validation of received documentation and translated documents
•    Proofreading coordination with subject matter experts such as clinical documents with medical team of Bayer.
•    Maintenance of record over Sharepoint.  

Artwork Review 
•    Performing artwork review in reference to updates available, which affect labels.
•    Artwork review using text verification tool (TVT) software (LATAM pharmaceutical portfolio)
•    Implementation of changes with compliance to internal procedures and local regulation
•    Precise track of changes and pro-active communication with involved functions in artwork review.
•    Perform artwork archive in the shared folder. 
•    Maintenance of record over Sharepoint. 

Change Management
•    Perform change management activity in SAP (BASICS). 
•    Involve in the review, approval/rejection of different work packages in SAP.
•    Prepare JOB AID/SOP for different activities. 

Requirements
•    Mandatory Knowledge of Global labeling, LATAM regulation and well adheres of Spanish language.
•    Should be advance level in English language 
•    Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously
•    Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance.  Adjusts behaviors to drive high quality deliverables
•    Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations, and takes a new perspective using existing solutions
•    Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
•    Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures
Key Attributes
•    Enthusiasm & confidence 
•    Adhere to our principles and values.
•    Time Management 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 Associate

Job ID: LIF006897

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Feb 11, 2022

Master Skills List: Operations

Job Category: Full Time