Manager - Regulatory Affairs
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Are you the one we are looking for?
We are inviting applications for the role of Manager, Regulatory affairs.
The person will be responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products.
Responsibilities:
1. Oversee day-to-day activities
2. Liaise with key interfaces on project requirements to ensure timelines are mutually understood.
3. Drafting responses to MAH for Health Authority queries.
4. Identify discrepancies/issues in local implementation of corporate labels.
5. Lead team for timely deliverables.
6. Monitor reference labels (from up to three countries) for updates and ability to connect with concerned affiliates directly using Sanofi communication/collaboration tools.
7. Maintaining updates related to labeling guidelines and regulations as they pertain to the development/maintenance of CCDS, US, EU and ROW labeling.
8. Ability to identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions
9. Must be able to construct a Company Response (MAH response) for health authority questions
Qualifications we seek in you!
Minimum qualifications
Bachelor's degree required in science, engineering or related field (advanced degree preferred).
Preferred qualifications
- Good communication 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. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.
Job: Manager
Job ID: CPG023145
Primary Location: India - Mumbai
Education Level: Bachelor's / Graduation / Equivalent
Job Posting: May 26, 2021
Master Skills List: Operations
Job Category: Full Time