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Manager - 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. Come, transform with us.

Are you the one we are looking for?

We are inviting applications for the role of Manager, Regulatory affairs! In this role, you are encouraged to be responsible for building various offerings in business insight area as requested by the clients on a regular basis. The individual must be an active contributor towards the overall objective of the project. We are looking for some who should be open to work in any shift as per the business requirement.

Responsibilities

The Role demands for a qualified professional who can provide mentorship to direct reports typically comprising of first line managers and supervisors.

  • Generation, review and/ or updating of SOP, BP, Mentorship BP and Work Instruction documentation
  • Generation, review and/or updating of process and/or training documentation
  • Review of metrics, reporting on trends and other analysis
  • Provide feedback to customers and partners on trending issues
  • Support in drafting of communications as they affect system users
  • Participate on system and process advisory boards and committees, and where vital act as system and/or process Subject Matter Expert(s) (SMEs)
  • Review, categorize, supervise and resolve system tickets for a variety of system issues
  • Collaborating closely with customers across several organizations, presenting with cross-functional partners and business process owners
  • System validation and data consolidation
  • Integration and migration support and strategy

Minimum Qualifications

  • Bachelor's degree required in science, engineering or related field (advanced degree preferred)
  • Broad functional knowledge of pharmaceutical sciences and clear understanding of drug development or manufacturing/improvement processes
  • Technical ability and aptitude for using Microsoft Office and Adobe software systems and tools
  • Ability to supply on cross-functional project teams, and optimally work with multiple fields and personalities.
  • Excellent communications skills (both written and verbal), with strong technical and regulatory writing ability. Should have a good understanding of CMC regulatory organisational change requirements and good manufacturing practices guidelines (GMP)

Preferred qualifications

  • Able to cultivate robust working relationships with the team, peers and clients, scheduling flexibility required
  • Overall candidate should have decision-making, macro-level research and analytics approach and good in numbers.
  • Good people and customer handling skills.
  • Effective communication and interpersonal skill.

 

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: Manager

Job ID: CPG019478

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Jan 11, 2021

Master Skills List: Operations

Job Category: Full Time