Senior/ Regulatory Specialist (Chemical Drugs), Therapeutic Products Branch

[What the role is]

Quality Evaluation of Therapeutic Products

[What you will be working on]

• Evaluate the Chemistry, Manufacturing and Controls (CMC) data of therapeutic product applications for regulatory approval to assure the quality of medicines supplied in Singapore.
• Provide advice / guidance on the regulatory requirements and procedures for therapeutic product regulatory submissions, and to respond to enquiries from industry and healthcare stakeholders as well as member of public.
• Participate in projects and process/regulatory review.

[What we are looking for]

• A background in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Analytical Chemistry or related disciplines. A post-graduate degree in areas such as organic chemistry, medicinal chemistry, pharmaceutical analysis, or drug development would be an advantage.

RELEVANT EXPERIENCE

• Minimum 5-7 years of experience in drug development, pharmaceutical manufacturing, quality control, or regulatory assessment of chemical drug products.
• Strong background in organic chemistry with knowledge of synthetic pathways and drug development processes.
• Knowledge of chemical manufacturing processes, process chemistry, and quality control strategies for chemical drugs.
• Knowledge of international drug regulations (ICH, FDA, EMA guidelines).
• Experience in analytical method development and validation would be an advantage.

RELEVANT SKILLS

• Good communication and interpersonal skills.
• Good writing and presentation skills.
• Able to analyse and integrate different sources of information to develop solutions.
• Able to work independently as well as in a team.
• Able to work effectively with people from other backgrounds, internal and external stakeholders.
• Highly motivated with strong desire to protect public health and safety.

• The successful candidate will be offered a 1-year contract (with option for automatic renewal for a further one year) in the first instance.
• Shortlisted candidates would be contacted within 30 days from the closing date of the advertisement. We regret that only shortlisted candidates would be notified.