Senior/ Regulatory Specialist (Biologics), 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 Molecular Biology, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, Pharmacy or related disciplines. A post-graduate degree in areas such as bioprocess engineering, molecular therapeutics, biologics development or mRNA/ nucleic acid therapeutic drug development would be an advantage.

RELEVANT EXPERIENCE

• Minimum 5-7 years of experience in pharmaceutical manufacturing, quality control, or regulatory assessment of biologics, mRNA products or other nucleic acid-based products.
• Knowledge of biologics development processes, including characterization studies, analytical method development and quality assessment.
• Knowledge of mRNA drug development processes, including lipid nanoparticle formulations, alternative delivery systems and associated manufacturing considerations or equivalent experience with nucleic acid delivery systems and formulation technologies.
• Knowledge of international drug regulations (ICH, FDA, EMA guidelines).
• Experience in analytical method development and validation for biologics 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.

• 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.