Regulatory Affairs Specialist

hace 3 días

Madrid, Madrid, España Reconocida empresa A tiempo completo
Regulatory Affairs Specialist

Reconocida empresa is seeking a highly skilled Regulatory Affairs Specialist to join our team in Singapore. As a key member of our Regulatory Affairs team, you will be responsible for preparing life cycle management submissions to the Health Authority.

Key Responsibilities:

  1. Receive and assess CLCN and CMC variations from the AP RMC to determine if submission to the local Health Authority is required.
  2. Provide detailed submission strategies to the AP RMC to ensure timely updating of compliance tracking systems.
  3. Prepare submission dossiers based on global dispatch and country-specific requirements.
  4. Coordinate with the RMC Liaison to resolve any issues with the submission package from global teams.
  5. Ensure accurate maintenance of country-specific requirements in CLRR or equivalent systems.
  6. Communicate submission and approval dates of life cycle management submissions to the RMC Liaison.
  7. Participate in team meetings, activities, and trainings as a full member of the LOC Regulatory Affairs team.

Requirements:

  • University degree in pharmacy, life sciences, or equivalent field.
  • 2+ years of relevant work experience in Regulatory Affairs (RA)/Government Affairs/Quality/Compliance/Manufacturing in medical or pharmaceutical companies.
  • Proficient in English (including technical RA English).
  • Experience working in a virtual team and/or global organization.
  • Knowledge of local regulations and international standards.

Desirable:

  • Project management skills and ability to build and lead project teams.
  • Detail-orientation combined with ability to understand issues from a big-picture perspective.
  • Analytical skills and technical RA knowledge.

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