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.