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Regulatory Submission Specialist
2 meses atrás
Welcome to one of the leading IT Services firms globally, where you can elevate your professional journey.
Why choose Tata Consultancy Services? At TCS, we recognize that our people are our greatest asset. We foster a culture of continuous learning filled with opportunities for personal growth and collaborative development. This is the perfect environment to share ideas using the right tools, contributing to our collective success.
We are seeking a Junior Submission Coordinator eager to learn and advance their career.
Key Responsibilities:
- Adhere to established Standard Operating Procedures and Work Instructions
- Ensure compliance with quality standards and turnaround time (TAT) targets consistently
- Compile, format, and submit electronic Common Technical Document (eCTD) regulatory submissions
- Conduct Quality Control checks on submissions promptly
- Oversee all technical aspects of assigned submissions and provide updates to relevant stakeholders
- Collaborate with program managers for the planning, preparation, publishing, and review of eCTD regulatory submissions
- Address additional submission requests for internal stakeholders
- Maintain a comprehensive understanding of Health Authorities' requirements for Safety Reporting
- Utilize regulatory systems for documenting adverse events and managing promotional labeling
Preferred Qualifications:
Essential Skills (3 to 5):
- Familiarity with Standard Operating Procedures and Work Instructions
- Commitment to meeting quality and TAT targets
- Experience in compiling, formatting, and submitting eCTD regulatory submissions
- Ability to perform timely Quality Control checks
- Proficiency in managing technical aspects of submissions and providing status updates
Desirable Skills:
- Two years of relevant regulatory experience; knowledge of publishing platforms, MS Office, and Adobe Acrobat
What We Offer:
- Comprehensive TCS Benefits in Brazil:
- Health and Dental Insurance
- Life Insurance
- Transportation and Meal Vouchers
- Childcare Support
- Gym Memberships
- 24/7 Psychological, Legal, Social, and Financial Assistance through TCS Cares
- Partnerships with SESC
- Certification Reimbursement
- Access to the Free TCS Learning Portal for online courses and live training
- Opportunities for International Experience
- Discounts with Universities and Language Schools
- Referral Bonuses through Bring Your Buddy Program
- Recognition Programs such as TCS Gems
- Free Mentoring through Xcelerate Career Platform
At Tata Consultancy Services, we promote an inclusive culture and strive for equity across all dimensions, including Gender, Disabilities, LGBTQIA+, Religion, Race, and Ethnicity. Our opportunities are rooted in these principles, and we are committed to actions that foster inclusion and social responsibility, creating a TCS that respects individuality. Become a part of TCS.
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