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Lead Consultant Regulatory Affairs, Labelling and Safety portfolio

Genpact

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. We dream in digital, dare, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We are harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we are calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing. People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower. 

Welcome to the relentless pursuit of better.

Inviting applications for the role of Lead Consultant Regulatory Affairs, Labelling and Safety portfolio

Experience in Labelling and Safety portfolio.

Responsibilities

The Role demands for Labelling and Safety submission expertise with demonstrating ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to

  • Safety submission related to PRAC Update, CCDS, PADER and PSUR 
  • Drafting responses to MAH for Health Authority queries.
  • Identify discrepancies/issues in local implementation of corporate labels.
  • Lead team for timely deliverables.
  • Monitor reference labels (from up to three countries) for updates and ability to connect with concerned affiliates directly using communication/collaboration tools. 
  • Maintaining updates related to labeling guidelines and regulations as they pertain to the development/maintenance of EU labeling.
  • Abilities to evaluate Change Controls and perform Impact Assessment.
  • Author and submit various safety variations to regulated and non-regulated Markets

Requirements

  • Masters in Lifesciences or equivalent with proven experience in regulatory Affairs/Labeling or equivalent 
  • Effective communication, time management, organizational skills and troubleshooting attitude. 
  • Knowledge of the principles and concepts of Labeling related to HMA and EMA
  • Abreast of international legislation, guidelines and customer practices on Signal detection.
  • 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

Qualifications we seek in you!

Pharmacy/Science 

Location

Mumbai

Shift

UK Shift (12.30 pm-9.00 pm)

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.

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.

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Confirmed 20 hours ago. Posted 30+ days ago.

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