About the Organisation
At vueverse, we are dedicated to connect exceptional talent with dynamic sectors, driving the future of industries through innovative recruitment solutions. We specialize in high-growth areas such as Emerging Technologies, MedTech, Pharma, Life Sciences, and Energy sectors, crafting bespoke strategies that cater to the distinct needs of each field. Our approach is deeply rooted in inclusive practices. We harness the power of role-based AI-driven screening, combined with our profound industry expertise, to ensure a smooth and effective hiring journey—from initial pre-screening to final onboarding. Our commitment extends beyond just business success. We are passionate about sustainability, striving to build teams that not only excel but also contribute positively to a sustainable future.
About the Job Opportunity
The Junior Regulatory Associate will support the Regulatory Affairs team in drafting, formatting, and reviewing regulatory documentation related to biosimilar submissions across key Asian markets. This entry-level role is focused on learning the regulatory submission process and contributing to document preparation and administrative regulatory tasks under supervision.
Job Responsibilities:
Document Drafting & Formatting
– Assist in drafting, formatting, and proofreading CTD/eCTD documents (Modules 1, 2, and 5) as per regional requirements.
– Prepare templates and assist in aligning Module 2 summaries (2.5, 2.7) with clinical study data and biosimilar justification sections.
– Maintain consistency in formatting, terminology, and structure across submission documents.
Regulatory Documentation Support
– Help collate data and documents from internal teams (CMC, Clinical, Safety, QA) for submissions.
– Perform initial document quality checks and organize files for regulatory review and publishing.
– Track document versions and maintain accurate records in regulatory document management systems.
Submission Planning & Coordination
– Assist in compiling submission checklists and timelines for various APAC markets.
– Coordinate with internal teams and publishing vendors to facilitate timely document finalization and submission readiness.
– Support status tracking of submissions and help compile response packages for agency queries.
Compliance & Learning
– Ensure document preparation follows internal SOPs, templates, and applicable regulatory guidelines.
– Participate in internal training to develop understanding of CTD structure, eCTD format, and regional regulatory frameworks.
– Contribute to document archiving, audit readiness, and compliance tracking.
Eligibility & Qualifications
– Bachelor’s degree in Pharmacy, Life Sciences, or related field (Master’s degree or regulatory certification preferred).
– 4 years of experience in regulatory affairs or scientific/medical writing
– Strong written English, attention to detail, and familiarity with MS Word and PDF tools.
– Willingness to learn eCTD structure, regulatory processes, and biosimilar regulatory pathways.
– Team player with good communication and organizational skills.
Contact Details
Click here to apply and for official notification.
