Submission Associate
Há 1 mês
Come to one of the biggest IT Services companies in the world Here you can transform your career
Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing to our success in a collaborative environment.
We are looking for Submission Associate - Junior, who wants to learn and transform his career.
In this role you will:
- Maintains familiarity and adheres to Standard Operating Procedures and Work Instructions
- Ensures that the defined quality and TAT targets are met at all times
- Compiles, formats, and submits eCTD regulatory submissions
- Performs Quality Control checks of submissions in timely manner
- Manages all technical aspects for assigned submissions and provides status updates to concerned parties
- Collaborates with program managers for planning, preparation, publishing, and reviewing of
- eCTD regulatory submissions
- Handles other submission requests for Roche counterparts
- Maintains full understanding of Health Authorities’ requirements for Safety Reporting
- Utilizes regulatory systems for reporting adverse events, advertising and promotional labeling
And much better if you stand out for:
Mandatory Skills (3 to max 5)
- Maintains familiarity and adheres to Standard Operating Procedures and Work Instructions
- Ensures that the defined quality and TAT targets are met at all times
- Compiles, formats, and submits eCTD regulatory submissions
- Performs Quality Control checks of submissions in timely manner
- Manages all technical aspects for assigned submissions and provides status updates to concerned parties
Desirable Skills:
- 2 years of related regulatory experience; familiarity with publishing platforms, MS Office, and Adobe Acrobat
What do we offer?
- TCS Benefits – Brazil:
- Health insurance
- Dental Plan
- Life insurance
- Transportation vouchers
- Meal/Food Voucher
- Childcare assistance
- Gympass
- TCS Cares – free 0800 that provides psychological assistance (24 hrs/day), legal, social and financial assistance to associates
- Partnership with SESC
- Reimbursement of Certifications
- Free TCS Learning Portal – Online courses and live training
- International experience opportunity
- Discount Partnership with Universities and Language Schools
- Bring Your Buddy – By referring people you become eligible to receive a bonus for each hire
- TCS Gems – Recognition for performance
- Xcelerate – Free Mentoring Career Platform
At TATA Consultancy Services we promote an inclusive culture, we always work for equity. This applies to Gender, People with Disabilities, LGBTQIA+, Religion, Race, Ethnicity. All our opportunities are based on these principles. We think of different actions of inclusion and social responsibility, in order to build a TCS that respects individuality. Come to be a TCSer
#Buildingonbelief
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