Senior/Regulatory Specialist (Quality), Therapeutic Products Branch

Health Sciences Authority; Singapore; On-site; SGD 50,000 - 80,000; Full time

Job summary

A leading company in Singapore seeks a qualified professional to evaluate therapeutic products for quality assurance. You will assess regulatory submissions, ensure compliance with health standards, and provide insights on quality control in pharmaceutical manufacturing. Candidates should have a strong background in related disciplines and excel in communication and analysis.

Qualifications

• Requires experience in pharmaceutical manufacturing and quality control.
• Knowledge of drug development processes and drug regulations is essential.
• Experience with analytical assay development is advantageous.

Responsibilities

• Evaluate Chemistry, Manufacturing and Controls (CMC) data for therapeutic products.
• Provide advice on regulatory requirements and procedures.
• Participate in projects and process/regulatory reviews.

Skills

Good communication

Interpersonal skills

Analytical skills

Education

Background in Molecular Biology, Biochemistry, Chemistry, or Pharmacy

Job description

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 approvals 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 reviews

What we are looking for:

• Background in Molecular Biology, Biochemistry, Chemistry, Pharmacy or related disciplines.
• Experienced in pharmaceutical manufacturing and quality control of biologics and / or chemical drug products
• Knowledge of drug development process and drug regulations
• Experience in the area of analytical assay development would be an advantage
• 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

Shortlisted candidates would be contacted within 30 days from the closing date of the advertisement. We regret that only shortlisted candidates would be notified.

About Health Sciences Authority

The Health Sciences Authority (HSA) applies medical, pharmaceutical and scientific expertise through its three professional groups, Health Products Regulation, Blood Services and Applied Sciences, to protect and advance national health and safety. HSA is a multidisciplinary authority. It serves as the national regulator for health products, ensuring they are wisely regulated to meet standards of safety, quality and efficacy. As the national blood service, it is responsible for providing a safe and adequate blood supply. It also applies specialised scientific, forensic, investigative and analytical capabilities in serving the administration of justice.For more details, visit http://www.hsa.gov.sg/.For more updates on public health and safety matters, follow us on Twitter at www.twitter.com/HSAsg and LinkedIn at https://sg.linkedin.com/company/health-sciences-authority.