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Regulatory Affairs Specialist

2 months ago

Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time
Job Title: Regulatory Affairs Specialist

At PHARMENG TECHNOLOGY PTE. LTD., we are seeking a highly skilled Regulatory Affairs Specialist to join our team in Singapore. As an integral member of our RA team, you will play a crucial role in supporting all regulatory activities, including the development and implementation of regulatory strategies, submission preparation, and regulatory approval across various therapeutic areas.

Key Responsibilities:
  • Prepare submission dossiers for post-approval variations within agreed timelines.
  • Maintain general knowledge of latest regulatory requirements.
  • Establish and maintain good working relationships with internal and external stakeholders.
  • Support investigation of regulatory compliance gaps with gap remediation plan development and implementation.
  • Determine regulatory relevance and perform variation assessments.
  • Develop and maintain regulatory databases as required.
  • Maintain and update regulatory files and records as required.
  • Ensure compliance with local regulations, corporate policies, and procedures.
  • Prepare and verify monthly reports, providing timely updates to relevant stakeholders.
  • Receive, gather, assess, and process information received from assigned stakeholders.
  • Provide administrative support where required.
Requirements:
  • Degree/Polytechnic Diploma in the Sciences (Pharmacy, Life Sciences, Biological Sciences, etc).
  • 1 year of experience in regulatory affairs or related work experience.
  • Good knowledge and understanding of pharmaceutical & scientific processes.
  • Good understanding of the regulatory environment, guidelines, and processes for product registration.
  • Attention to detail.
  • Ability to work with data and basic regulatory SOPs.
  • Takes ownership of tasks and strong ability to collaborate with team members.
Ideal Background:
  • BSc in health-related science, life science, Pharmacy degree desired.
  • English - fluent in speaking and writing.