Genpact Mumbai Hiring DG – Sr. Manager – Regulatory Affairs

Genpact Mumbai Hiring DG – Sr. Manager – Regulatory Affairs

21 February, 2022

About the job

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.

Inviting applications for the role of SM, CMC Scientist

Responsibilities

  • Serve as the CMC Product Lead (or support the Global Regulatory Lead) for assigned products supporting the delivery of all regulatory milestones for assigned products through the product lifecycle.
  • Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
  • Lead the post-approval changes management for assigned CMC products
  • Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
  • Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal.
  • Collaborate with client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
  • Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
  • Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
  • Assess and communicate potential regulatory risks and propose mitigation strategies.
  • Deliver all regulatory milestones for assigned products across the product lifecycle
  • Identify, communicate and escalate potential regulatory issues to CMC management, as needed

Qualifications

Minimum qualifications

Bachelor’s degree required in science, engineering or related field (advanced degree preferred)

Preferred Qualifications

Relevant experience, including research; manufacturing, testing, or licensure of pharmaceutical, vaccine, or biological products; or related fields.

Apply through below link:

https://www.linkedin.com/jobs/view/2870997253/?alertAction=markasviewed&savedSearchAuthToken=1%26AQEFv0QS4QAXCgAAAX8YNZBd0oIzvimcl229jaAWNEs_474tg-aVgSAyZNH2XVruMHuz9IY5ctk27pryjVY25KL4WRicXllvEKHZqI2UYa1yLZGHncWh2vbyM7ITqvwdnCiTaUzDoWbVn4zEOLDz5K4Z_UqCCH9GMV8P0HN3AgOLFJReh4GLyGG0swm8s0lkeL5J5HOGc5iWgMIgBnLf0ro08uXlRri7Lw1dObYg-ftCW8lDyJiNU9m7OCWxM4vjCNP1HqhOMfwKJSn5t69TsmhdeADmeuIdOXO1a4MGPcE33MZuw90iK00%26AZZ1K38syooAFTN-dVZYifEwQA1P&savedSearchId=1723689795&refId=4eab9c6d-f42c-4982-a938-e016801f5ee4&trackingId=pXc%2FnAIKMRQpYL3OkaNwug%3D%3D&midToken=AQHe5DI7JhynNA&midSig=3jw9JhlVQ1sq81&trk=eml-email_job_alert_digest_01-job_alert-11-member_details_mercado&trkEmail=eml-email_job_alert_digest_01-job_alert-11-member_details_mercado-null-zetr5%7Ekzvjyhwf%7Eab-null-jobs%7Eview

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 building 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

Senior Manager

Primary Location

India-Mumbai

Schedule

Full-time

Education Level

Bachelor’s / Graduation / Equivalent

Job Posting

Jan 10, 2022, 4:58:14 AM

Unposting Date

Ongoing

Master Skills List

Operations

Job Category

Full Time

Leave a Reply

Your email address will not be published. Required fields are marked *