Lead consultant Labeling 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 •    Liaise with key interfaces on project requirements to ensure timelines are mutually understood. •    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 Sanofi communication/collaboration tools.  •    Maintaining updates related to labeling guidelines and regulations as they pertain to the development/maintenance of CCDS, US, EU and ROW labeling.

Minimum Qualifications and Experience  •    Masters in Lifesciences or experience in regulatory Affairs/Labeling or equivalent  •    Knowledge of the principles and concepts of Labeling •    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, colour, 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.   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.