Pharmaceutical Regulatory Compliance Specialist

5 days ago

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

We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in pharmaceutical regulatory affairs, with a focus on managing the preparation and submission of regulatory documentation to health authorities.

Key Responsibilities:

  • Ensure compliance with national and international regulatory requirements throughout the product lifecycle.
  • Approve labels, packaging, and promotional materials for compliance.
  • Summarize scientific data and prepare regulatory dossiers for new product approvals, renewals, and variations.
  • Manage timely submissions to regulatory agencies and communicate effectively with health authorities.
  • Track regulatory changes and review product materials for compliance.
  • Support clinical trials and maintain regulatory databases.

Required Skills and Qualifications:

To qualify for this role, you should hold a Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field, along with 4-5 years of experience in pharmaceutical regulatory affairs. Strong knowledge of global regulatory requirements is essential, as well as attention to detail, critical thinking, organizational skills, and excellent communication skills.

Preferred qualifications include Regulatory Affairs Certification (RAC) or equivalent, familiarity with global submission platforms, and experience in new drug applications and post-marketing surveillance.

Benefits:

This is a full-time position offering benefits such as cell phone reimbursement, day shift schedule, and a performance bonus.

Why Work With Us:

If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply. Join our dynamic team and contribute to shaping the future of pharmaceutical regulations.

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