Regulatory Affairs Specialist

2 weeks ago

Singapore beBeeRegulatory Full time $80,000 - $120,000
Job Title: Regulatory Affairs Specialist

We are seeking a skilled Regulatory Affairs Specialist to monitor emerging regulatory trends and ensure they are integrated into company procedures.

  • Trend Monitoring
  • Support regulatory submissions, product registrations, renewals, and variations across domestic and regional markets.
  • Assess product, manufacturing, labeling, and packaging changes for regulatory compliance.
  • Provide input for product development, clinical studies, and manufacturing transfers.
  • Liaise with regulatory authorities; assist in negotiations and field actions.
  • Act as an internal consultant on regulatory issues, including recalls, safety reporting, and promotional activities.
  • Prepare reports, submissions, presentations, and maintain regulatory documentation.
Requirements:
  • Bachelor's degree in a science-related field.
  • Minimum 2-3 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
  • Familiarity with regulatory affairs such as NDA, variation, and renewal of product registrations is advantageous.
  • Pharmacovigilance experience preferred but not mandatory.
Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with regulations.
  • Monitor and analyze regulatory updates and trends.
  • Collaborate with cross-functional teams to ensure regulatory requirements are met.
  • Prepare and submit regulatory documents and reports.
Why You'll Thrive:
  • Opportunity to work with a dynamic team.
  • Challenging role with opportunities for growth and development.
  • Competitive compensation package.

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