About this role

Coordinate the preparation, compilation, and submission of new drug applications and Lifecycle Manage (LCM) activities
Organize the submission team meetings (“Kickoff Meeting”)
Facilitate effective communication among all stakeholders including CMC, labelling, RRL, Local Regulatory Responsible (LRR) or Regulatory Partner Representative (RPR)
Prepare the Submission Content Plan (SCP) based on country-specific regulatory requirements
Support the M1 documents preparation
Ensure appropriate archiving of labeling documentation
Track the dispatched documentation for each country
Proactively identify potential project issues, risks, and roadblocks that may impact submission timelines

Bachelor's degree in Life Sciences, Pharmacy, or related field
3-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
Strong understanding of regional regulatory submission processes
Experience with different international regulatory submission routes preferred (e.g. ACCESS, reliance pathways)
Excellent project management and organizational skills
Strong communication and stakeholder management abilities
Proficiency in regulatory tracking systems and Microsoft Office Suite
Ability to work collaboratively across global and regional teams

Regulatory Affairs Consultant – Regional Submission Coordinator

Key skills