Regulatory Metadata Coordinator

Pharma and Clinical Research

INTRODUCTION

Tata Consultancy Services (TCS) is an IT services, consulting, and business solutions provider partnering with the world’s largest businesses in their transformation journeys.

Currently, we are looking for our new Regulatory Metadata coordinator, who will perform in accordance with our client’s business activities.

FUNCTION

  • Attends any RA project management meeting to be updated of any regulatory activity in relation to allocated products.
  • 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 stakeholders
  • Controls the quality of the data entry executed internally or by Service Provider(s)
  • Maintains a continuous flow of information to and from Publishing, GRA, LRAs and Regulatory
  • Operations teams with regards to tracking.
  • Provides training, coaching and mentoring to RA community on the tracking of regulatory information.
  • Contributes to the improvement of regulatory data entry process in performing pilot tests key stakeholders.
  • Contribute to the maintenance of quality documentation (e.g., SOP, INS)
  • Assists the regulatory system owners with their system enhancement projects.
  • Maintain the metadata collection tool in line with regulatory tracking system evolution
  • Propose improvements to the regulatory tracking system and relative documentation based
  • on daily use.
  • Maintain up-to-date instruction, internal guide relating to the Data Entry activity

REQUIREMENTS

  • Bachelor Degree in Lifesciences/Pharmacy preferred
  • Up to 5 years of experience in Regulatory affairs and submission, with Corporate experience
  • Skills in standard software packages, and Regulatory Information Management (RIM) tools/ Regulatory tracking system preferred
  • 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

OFFER

  • TCS has been delivering services from Hungary since 2001, making us a perfect choice if you’re looking for stability.
  • We provide a wide range of benefits, including a market leading comprehensive private health care package.
  • We offer extensive self-development opportunities: our colleagues have a multitude of training possibilities for personal and professional growth.
  • At TCS Hungary there are both vertical and horizontal career options for those who like to challenge themselves and try out different areas and positions.
  • You will be part of a global and diverse working environment with relaxation areas, terraces, and a friendly atmosphere.
  • You can seize the day with us at our company events, hobby clubs, and sporting initiatives.
  • An attractive compensation package.

CONTACT INFO

For additional details about the role, please visit https://tinyurl.com/yknrkucz
And to learn more about our data protection policy, visit http://on.tcs.com/hungaryprivacynotice