Regulatory Affairs Specialist

2 weeks ago

Singapore beBeeRegulatory Full time $80,000 - $140,000

Job Title: Regulatory Affairs Specialist

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  • This is a unique opportunity to leverage your expertise in regulatory affairs and medical writing to drive business success.
  • The ideal candidate will possess strong analytical skills, excellent communication abilities, and the ability to work effectively in a collaborative environment.
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Responsibilities:

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  • Develop comprehensive regulatory documents and submissions to ensure compliance with global regulations and standards.
  • Collaborate with cross-functional teams to gather and analyze data for regulatory submissions.
  • Utilize MS Excel and MS Office to create detailed reports and presentations for regulatory purposes.
  • Conduct thorough research and analysis to support regulatory strategies and decision-making processes.
  • Maintain up-to-date knowledge of regulatory requirements and industry trends to inform best practices.
  • Provide expert guidance on regulatory affairs and medical writing to internal stakeholders.
  • Review and edit regulatory documents to ensure clarity accuracy and compliance with guidelines.
  • Coordinate with research and development teams to align regulatory strategies with project goals.
  • Monitor and track regulatory submissions and approvals to ensure project timelines are met.
  • Support the development and implementation of regulatory policies and procedures.
  • Communicate effectively with regulatory agencies and external partners to facilitate approvals.
  • Contribute to the continuous improvement of regulatory processes and documentation standards.
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Requirements:

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  • Proficiency in MS Excel and MS Office for regulatory documentation and reporting.
  • Strong understanding of Regulatory Business Process Services and Regulatory Affairs.
  • Experience in Research and Development within the regulatory domain.
  • Ability to work collaboratively in a hybrid work model.
  • Attention to detail and accuracy in regulatory documentation.
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Certifications:

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  • Regulatory Affairs Certification (RAC) or equivalent certification in regulatory affairs.
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