skillindiajobs
Register for Job
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Lead Associate - Regulatory Affairs

1.00 to 6.00 Years   Mumbai City   15 Feb, 2022
Genpact India Pvt Ltd
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaERP / CRM
EmploymentTypeFull-time

Job Description

    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.,

Keyskills :
customer relationsreportingslaaccountsbasisms office toolssubject matter expertscontinuous improvement facilitationms officecore data

APPLY NOW

Lead Associate - Regulatory Affairs Related Jobs

© 2020 Skillindia All Rights Reserved