Genpact (NYSE: G) is a global professional services firm that delivers innovative solutions to shape the future. With over 125,000 employees in more than 30 countries, Genpact is committed to creating lasting value for clients through its deep industry knowledge, digital operations services, and expertise in data, technology, and AI. We are currently inviting applications for the role of Technical Associate, CMC Regulatory Affairs.
Responsibilities
As a Technical Associate, CMC Regulatory Affairs, you will play a vital role in managing the regulatory aspects of CMC activities and submissions. Key responsibilities include:
- Labelling Variations: Preparing local documents such as Cover Letters, electronic application forms, and updating German product information texts.
- CMC Variations: Reviewing documents from CMC, adding local information, and updating submission content plans.
- Veeva Management: Creation and maintenance of Veeva activities such as ROs, Submissions, Registrations, and more in Veeva Vault.
- Coordination: Ensuring on-time delivery of documents, coordinating artwork updates, and maintaining product information texts.
- Regulatory Data Management: Managing and QC-ing regulatory databases, ensuring compliance with local regulations, and updating product information in Veeva Vault.
- HA Interaction & Post-Approval Commitments: Coordinating regulatory activities, providing regulatory intelligence, and interacting with partners.
- Cross-functional Coordination: Supporting dossier preparation and review, ensuring high-quality global filings and timely approvals.
- Risk Management: Identifying and communicating risks related to major CMC activities that have regulatory or financial impacts.
Qualifications
Minimum Qualifications
- Education: Master’s degree in Pharmaceutics, Chemistry, Biology, or a related field.
- Experience: Required experience in CMC Regulatory Affairs.
Preferred Qualifications/Skills
- Strong interpersonal and communication skills.
- Proficiency in English.
- Initiative and the ability to work independently.
