Genpact Hiring Lead Consultant – Reg. Affairs-LIF007653 – India-Mumbai

Genpact

  • Full Time

Job Title : Lead Consultant – Reg. Affairs-LIF007653

Location : India-Mumbai

Lead Consultant – Reg. Affairs-LIF007653

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. 
 Transformation happens here. Come, be a part of our exciting journey!
Are you the one we are looking for?
Inviting applications for the role of Assistant Manager, Publisher!

The Role demands an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process-driven environment.
Responsibilities
•    Publishing and performing final technical quality review and technical validation (eCTD/NeeS) for US, LATAM and Canadian Submissions.
•    Notifying relevant stakeholders that the Submission is ready for approval
•    Dispatching submission to the relevant authority (eCTD, NeeS, paper) or affiliate so that affiliate can dispatch to authority. 
•    Performing post-submission processing activities such as receiving acknowledgement from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders. 
•    Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata. 
•    Monitoring and reporting submissions activity, such as reporting volume, timelines, and quality metrics; informing future planning and forecasting activities; supporting overall regulatory intelligence.
Qualifications we seek in you!
Minimum qualifications
•    B. Pham/M.Pharm/Science Graduate  
•    In depth working knowledge of industry standard publishing systems and desktop applications.
•    Expertise with Publisher applications    
•    Effective communication, time management and organizational skills.
•    Trouble shooting 
•    Flexibility to adapt to a changing environment, 
•    Demonstrated project management and leadership skills. 
•    Skilled at fostering customer relationships and driving collaboration.
•    Understanding of global regulatory processes and requirements.
•    Strong attention to detail, ability to multi-task.
•    Expertise with industry standard electronic document management system
•    Experience and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing  Tools like Liquent, Docubridge, etc.

Preferred Qualifications 
•    Experience in Pharmacy Regulatory Affairs

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.

 

 

JobLead Consultant
Primary LocationIndia-Mumbai
ScheduleFull-time
Education LevelBachelor’s / Graduation / Equivalent
Job PostingMay 13, 2022, 7:32:01 PM
Unposting DateOngoing
Master Skills ListOperations
Job CategoryFull Time

Job Overview