Regulatory Affairs Coordinator

We are seeking a highly skilled Regulatory Affairs Coordinator to join our team at 696 GlaxoSmithKline Mexico S.A. de C.V. as a Sr Submission Coordinator. This role will play a critical part in ensuring the timely and compliant delivery of submissions to regulatory authorities.

• Collaborate with the Global Regulatory Lead, Regulatory Matrix Team, and global submission teams to deliver submissions in accordance with regulatory authority regulations and guidelines.
• Lead key activities to progress your career, including:
  • Accountable for the delivery of Marketing Application, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines.
  • May be responsible for leadership of relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product.
  • May be required to perform scenario planning when multiple regulatory strategies are being considered and propose delivery strategies to achieve accelerated timelines.
  • May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.
  • May be the primary contact for the GRL, maintaining the overall RMT workplan (including relevant regulatory milestones according to the phase of development).
  • May be required to provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets.
  • May be required to lead or participate in process improvement initiatives.
  Requirements
  • Degree in a biological, healthcare, or scientific discipline.
  • 5+ years of experience in Regulatory Affairs.
  • Advanced English level.
  • General understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
  • General knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV.
  • Ability to interpret regulations and gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
  • Ability to work in a matrix environment, ensure delivery of objectives across cross-functional teams.
  • Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
  • Availability to work 2 days at office.
  Desirable Skills
  • Project Management courses or experience.
  • Veeva Vault.
  • International Regulatory Affairs Knowledge.