INTRODUCTION

As a Junior Regional Submissions Planner you will have the opportunity to support one of the world’s most prestigious pharma companies. You will work within the MSD Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regulatory Affairs Operations Regional department for Europe, Middle East and Africa [EMEA]). You will be part of a multicultural team helping develop and apply strategies to ensure regulatory compliance.

FUNCTION

• Support other planners in review and manage the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs of regional regulatory authority for simple submissions
• Project management including managing dynamic timelines, interacting and negotiating and collaborating with global stakeholders under guidance from senior planners
• submission planning,
• document retrieval,
• submission creation
• delivery to Health Authorities
• Support the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective for the assigned region
• Carry out activities as assigned by manager

REQUIREMENTS

• Degree in a Life Science related discipline
• 6-12months of experience in the regulatory operations area
• Good knowledge of MS Office tools (Word, Excel, and PowerPoint)
• Business fluency in English
• Advantage: Experience in Regulatory Submissions and/or regulatory publishing; Experience in process development / process improvement (Lean/Sigma Green/Black belt); Experience in tool development (especially regarding project management/submission planning)

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

Dr. Noemi Farkas-Hussey
Email address: noemi.farkashussey@tcs.com