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DG - 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.

 

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 Lead Consultant, Bayer Publisher!

The Role demands for 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) for Canada submissions.
  • Knowledge of IND, DMF, NDA, and BLA submissions. E, g Safety Submissions, Annual reports, OPDP submissions, Protocol and amendment, Original application.
  • Notifying relevant stakeholders that the Submission is ready for approval
  • Dispatching submission to Canada FDA through ESG.
  • Performing post-submission processing activities such as receiving acknowledgment from the authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders; 
  • 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

  • Graduate in Pharmacy/Science
  • Good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, eCTD Manager, etc.
  • In-depth working knowledge of industry-standard publishing systems and desktop applications.
  • Expertise with Publisher applications 
  • Effective communication, time management, and organizational skills.
  • Troubleshooting 
  • 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 the industry-standard electronic document management system
  • Publishing and/or related Regulatory/Pharmaceutical area

 

Preferred qualifications

  • Postgraduate in Pharmacy/Science

 

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: LIF006009

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Sep 23, 2021

Master Skills List: Operations

Job Category: Full Time