Regulatory affairs- Domain Trainee- English-Remote Poland
Genpact
0 - 3 years
nan
Posted: 3/5/2025
Job Description
Responsibilities
Support through a number of regulatory functions specific to post-approval, lifecycle management capacities which includes -
Sound knowledge and experience in handling and managing CMC and labelling related Variations for EU / EMEA region guidelines and procedures
Preparation of documentation for EMA notification, Submission to EMA, HA interactions for MRP/DCP
Management of ancillary documents along with sample requests for European countries
Communicate with EMA for Worksharing & super-grouping referral procedures
Co-Author of PSUR (RA responsible for specific sections)
First entry point for all kind of questions from Country representatives
Participate at Supply Interruption Calls (SIC)
Follow up activities like recall, DHCP communication etc.
Contribute to internal notification process
General tasks:
Support and coordination of audit and inspection related activities
Maintain up-to-date knowledge of regulatory requirements and guidelines
Provide regular progress reports and updates
Experience:
Extensive years of relevant experience in EU market managing CMC tasks and related aspects.
Qualification:
Atleast Bachelor's degree required in for Pharmaceutical: science, engineering, or related field (advanced degree preferred).
Language: Basic German is good to have, not mandatory
About Company
Genpact is a global professional services firm that offers a wide range of digital transformation services and solutions. With a presence in over 30 countries, Genpact leverages its deep domain expertise in operations and analytics to help businesses transform their operations, improve efficiency, and enhance customer experience. The company combines digital technology, data science, and operational excellence to deliver business outcomes across various industries, including banking, insurance, manufacturing, and healthcare. Founded in 1997 as a subsidiary of GE, Genpact has grown into an independent, NYSE-listed company with a diverse workforce of over 90,000 employees globally.
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