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Semesteria

Senior Regulatory Affairs Specialist

Semesteria

Posted

yesterday

Jurong West, West Region, Singapore

Onsite

SGD 6K

Senior Level

Full Time

Match

Skills

Experience

Industry

Sema

Sema Summary

The Senior Regulatory Affairs Specialist will oversee compliance with regulations in Jurong West, Singapore. Responsibilities include ensuring product approvals and maintaining communication with regulatory bodies. The position requires extensive knowledge in regulatory processes and experience in managing submissions. Candidates should have a proven track record in regulatory affairs and exhibit strong analytical and communication skills. This is a full-time role requiring onsite presence.

About Company

At Semesteria, we specialize in compliance and regulatory affairs within the healthcare sector, ensuring our clients meet all necessary legal standards effectively.

Core Requirements

  • Bachelor's degree in Life Sciences or related field
  • Minimum 5 years of experience in regulatory affairs
  • Strong knowledge of local and international regulations
  • Ability to work collaboratively with cross-functional teams
  • Excellent communication skills

Responsibilities

  • Manage regulatory submissions and approvals
  • Monitor changes in legislation affecting the industry
  • Prepare and submit documents to regulatory agencies
  • Collaborate with product development teams
  • Conduct regulatory training for internal teams
  • Act as a liaison with external regulatory bodies
  • Ensure compliance with all relevant regulations and guidelines

Must Have skills

Regulatory knowledgeSubmission managementAnalytical skillsCommunication skillsTeam collaboration

Nice To Have Skills

Project managementStrategic planningProblem-solving skillsKnowledge of healthcare standardsRisk assessment

Job Keywords

Regulatory AffairsComplianceHealthcareDocumentationSubmission

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