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.

Minimum 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

What can we offer?
Attractive salary;
Stable job offers - employment contract
Work in a multicultural and diverse environment with employees from over 30 countries
Genpact supports professional trainings and great career development opportunities
Free access to our award-winning learning platform
Benefits such as Insurance, Luxmed, additional vacation days, biking policy

As an Equal Opportunity Employer we encourage you to apply to this opening position(s) with your preferred CV format. Please note that Genpact does not impose any CV format, nor do we require you to enclose a photograph with your CV as part of the application process. It is the candidates absolute discretion if he/she chooses to upload a CV with or without a photograph enclosed.

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