Senior Regulatory Affairs Specialist

2 weeks ago

Singapore beBeeRegulatory Full time $150,000 - $200,000
Regulatory Affairs Leader

Precision Medicine is a pioneering Clinical Research Organization that combines cutting-edge clinical trial execution with expert scientific knowledge, laboratory expertise, and advanced data analytics.

The successful candidate will lead teams responsible for regulatory submissions worldwide. They will provide strategic guidance and support for all regulatory and ethics submissions in relation to Clinical Trials and drug development, including Health Authority interaction, attending meetings, and provision of strategic regulatory support to other departments, project teams, and committees.

Main Responsibilities:

  • Provide technical and regulatory guidance to clients and team members in the area of clinical development of human medicinal products and drug development life cycle
  • Establish operational objectives and assignments for assigned team members
  • Track and report regulatory function metrics and key performance indicators
  • Oversee, review, and provide strategic input on applications to Regulatory Authorities, including CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and expedited pathways

The Regulatory Affairs Leader will contribute to the growth and enhancement of the Regulatory department, facilitating business development and proposals in this area.

Requirements:

  • Post Graduate Degree, Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
  • 10+ years or more relevant regulatory affairs experience in CRO, Pharma, Biotech, or related industry
  • Extensive and broad knowledge and experience of all aspects of drug development process, including subject matter expertise in regulations and guidelines (including NA, EMA, APAC, national authorities, and IHC/GCP/GMP)

About Precision Medicine:

Precision Medicine is a precision medicine Clinical Research Organization offering an integrated solution that enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unwavering commitment to rare diseases and oncology, as well as working across other therapeutic areas.

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