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Regulatory Metadata Coordinator job in Budapest at TATA Consultancy Services - Hungary

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Regulatory Metadata Coordinator at TATA Consultancy Services - Hungary

Regulatory Metadata Coordinator

TATA Consultancy Services - Hungary Budapest, Budapest, HU Full Time
Required languages: English
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Do you have pharma regulatory experience? Have you done project Coordinator role in the pharma regulatory in submission or Publishing? Are you looking for full-time job?

If you are, read on, we have a great opportunity for you to support one of the world's most prestigious pharma companies. You will be part of a multicultural team helping develop and apply strategies to ensure regulatory submission and compliance. You will have the opportunity to be a key link of communication with our stakeholders. You can develop your career in a global environment while contributing to health and safety of the patients.

  • To assist the Publishing & Regulatory Data Entry Manager in providing Global Submission view and strategy Worldwide, in line with Regulatory Strategic Planning.
  • To ensure that metadata submitted to the Health Authorities (HA) and coming from HA are accurate and that Regulatory tracking system is aligned.
  • To assess Submission strategy impact on Regulatory Tracking System and ensure that
  • Regulatory Tracking System is appropriately maintained.
  • To oversight Service provider(s) for the Centralized Data Entry and HA document upload activities
  • Promotes/Communicates on Regulatory Data process/timeline with RA community, and contributes to the planning of the regulatory submission.
  • Ensures that accurate and up-to-date regulatory information on products, under development, approved and marketed, worldwide is available to all stake-holders.
  • Maintains a continuous flow of information to and from Publishing, GRA, LRAs and Regulatory Operations teams in particular with regards to tracking.

Requirements

Strong analytical and problem-solving capability with attention to detail

  • Strong written and oral communication skills
  • Must exhibit excellent interpersonal, collaborative and team spirit mindset, good communication and follow-up skills
  • Good judgment and decision-making skills
  • Good negotiating and influencing skills
  • Excellent planning, co-ordination and Project Management skills
  • Willingness to work in a fast-paced environment with stringent timelines
  • Experience in continuous improvement projects and quality management

Advantages:

  • Bachelor Degree in Lifesciences/Pharmacy preferred
  • Up to 2 to 4 years of experience in Regulatory affairs and submission, with Corporate experience

WHAT DO WE OFFER?

In our Shared Service Center you can taste the world by working together with more than 90 nationalities. As part of the Tata Group, India’s largest multinational business group, TCS has over 450,000 of the world’s best-trained consultants in 46 countries.


This position belongs to the BPS (Business Process Solutions) unit. This unit is helping enterprises achieve significant and sustained business outcomes by leveraging our deep domain expertise and operations.

As a future TCSer, you will be provided with:

  • A career path that will allow you to become a Subject Matter ExperGet trained on various competencies and skills
  • A great diversity of cultures
  • Language courses and training
  • On-site relax & gym rooms
  • Volunteering, sport and employee events
English (Business Fluency)

Recommended Skills

Decision Making
Complex Problem Solving
Quality Management
Continuous Improvement Process
Training
Operations

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Job ID: 1592