Junior Regulatory Affairs Associate

Junior Regulatory Affairs Associate

Location: Remote working from home with flexibility to travel occasionally for team meetings or training

Role Summary:

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.

Key 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.

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.