Senior Specialist in Regulatory Affairs

6 days ago

Singapur, Singapore Careers@Gov Full time
Position Overview

The Health Products Regulation Group (HPRG) at Careers@Gov is dedicated to ensuring that pharmaceuticals, cutting-edge therapies, medical devices, and health-related products are effectively regulated to meet essential safety, quality, and efficacy standards. HPRG plays a pivotal role in advancing biomedical sciences by implementing a robust and responsive regulatory framework in Singapore.

The Innovation Office and Clinical Trials Branch (IOCTB) within HPRG oversees the regulation of clinical trials in Singapore. This includes evaluating clinical trial submissions and offering early regulatory consultations to facilitate the development of innovative therapeutic products.

We seek a highly skilled and experienced professional to join our team as a Senior Regulatory Specialist. This role involves providing and leading regulatory and scientific guidance to stakeholders, as well as conducting thorough scientific reviews of data to ensure the safe use of investigational products in clinical trials. The specialist will also support innovative product development and assist in the approval processes within Singapore.

Key Responsibilities:

  • Deliver and lead regulatory and scientific advice to stakeholders to promote efficient development of innovative therapeutic products.
  • Conduct and oversee scientific reviews, providing recommendations on clinical trial applications and new drug submissions.
  • Contribute to stakeholder training, communication, and engagement initiatives.
  • Lead and contribute to the review and development of regulatory policies and guidance, ensuring efficient operations and effective project implementation.
  • Stay updated on emerging scientific advancements related to novel technologies and product types, providing strategic and scientific insights to ensure the regulatory framework remains responsive to new developments.
  • Represent Singapore's interests and contribute to networking, development of harmonized technical guidance, and regulatory collaborations at national, regional, and international levels.

Qualifications:

  • Possess knowledge and experience in relevant scientific fields such as Medicine, Pharmacy, Pharmacology, Toxicology, Immunology, Infectious Diseases, Oncology, Genomics, and Biomedical Sciences.

Experience:

  • 2 to 10 years of regulatory and/or scientific experience in non-clinical, quality, or clinical development of therapeutic products within the pharmaceutical industry or academia.
  • Familiarity with the drug development process, regulatory requirements, Good Clinical Practice (GCP) guidelines, and other relevant scientific guidelines.
  • Expertise in scientific disciplines pertinent to drug development, including clinical pharmacology, toxicology, molecular biology, and regulatory science, is advantageous.
  • Knowledge of the local biomedical sciences landscape is a plus.

Personal Attributes:

  • Critical and strategic thinker with strong analytical skills, capable of interpreting and communicating technical data effectively.
  • Demonstrated ability to facilitate or lead meetings, make impactful presentations, and engage collaboratively with internal and external stakeholders.
  • Effective oral and written communication skills, able to engage confidently and diplomatically with various stakeholders.
  • Able to engage and work effectively with external domain experts as necessary.
  • Proven ability to lead projects to deliver results.
  • Self-directed learner, proactive, and capable of thriving in a fast-paced environment.
  • Able to prioritize work according to timelines.

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