Senior CTA Submissions & Regulatory Lead (EU CTR)

Nusantara Prime Consulting Pte. Ltd.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Nusantara Prime Consulting Pte. Ltd. is seeking an experienced CTA regulatory professional in Singapore to manage CTAs, support regulatory submissions, and guide cross-functional teams through CTR processes.

The role requires strong IT skills, excellent communication, and the ability to work independently in a multicultural, matrix environment. 12-month contract with opportunities for training and process optimization.

Qualifications

• Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences is required.
• Relevant advanced degree in life sciences is preferred.

Responsibilities

• Manage a portfolio of CTAs including preparation and distribution of documentation for new CTAs and all CTA maintenance activities.
• Provide advice on submission strategy and country requirements, plus operational support for regulatory submissions and amendments.
• SME on EU CTR submissions including platform and complex trials, guiding cross-functional teams and training on processes.

Skills

Regulatory submissions

Cross-cultural teamwork

Information Technology

Communication skills

Initiative

Independent work

Education

Bachelor's degree in life sciences

Advanced life sciences degree preferred

Tools

MS Word

MS Excel

PowerPoint

Adobe Acrobat

Global databases

Job description

Nusantara Prime Consulting Pte. Ltd. is seeking an experienced CTA regulatory professional in Singapore to manage CTAs, support regulatory submissions, and guide cross-functional teams through CTR processes.

The role requires strong IT skills, excellent communication, and the ability to work independently in a multicultural, matrix environment. 12-month contract with opportunities for training and process optimization.