Manager, Regulatory affairs.-LIF019289

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

Inviting applications for the role of Manager, Regulatory affairs.

In this role, you will be expected to work on deadlines, in a fairly high pressure business environment while being a good great teammate.

Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy

Responsibilities

• Updating and maintenance of harmonized/regional labeling including artwork for inserts and packaging components
• Liaise with key interfaces on project requirements to ensure timelines are mutually understood.
• Liaise with Labeling Manager to understand nature of change, urgency, important information for affiliates and/or implementation
• Prepare global dispatch of core label information, including notice to affiliates
• Enter data into systems pre-dispatch and update systems with post-dispatch activities (Appian, Vault, Vista)
• Competitive labeling analysis as needed and/or requested
• Monitor reference labels (from up to three countries) for updates and ability to connect with concerned affiliates directly using Sanofi communication/collaboration tools.
• Identify discrepancies/issues in local implementation of corporate labels
  
  

Minimum Qualifications / Skills

• Masters in Lifesciences or equivalent with more years of experience in regulatory Affairs/Labeling or equivalent
• Knowledge of the principles and concepts of Labeling, knowledge of the principles and concepts of Labeling, including generics, authorized generics, private labels, device/combination products, how to read and interpret HA regulations and guidance, and underlying SOPs
• Ability to identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions
• Must be able to construct a Company Response (MAH response) for health authority questions
• Preferred qualifications
• Excellent communication and PC skills
  
  

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. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.

Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.

Job

Manager

Primary Location

India-Hyderabad

Schedule

Full-time

Education Level

Bachelor's / Graduation / Equivalent

Job Posting

Dec 6, 2024, 12:24:13 PM

Unposting Date

Ongoing

Master Skills List Operations

Job Category Full Time