Remote Senior Associate Regulatory Affairs

3 weeks ago

Mumbai, India Cliniminds Full time

Cliniminds is hiring Senior Associate Regulatory Affairs on behalf of globsl consulting company.

Role Summary:

The Senior Regulatory Associate plays a key role in supporting regulatory submission activities across Asian markets, primarily for biosimilar products. This role involves hands-on drafting, quality checking (QC), and performing Level 1 review of eCTD documents, ensuring alignment with internal standards and regulatory expectations. The position requires a proactive and detail-oriented professional capable of managing document workflows, contributing to submission quality, and coordinating with cross-functional teams.

Key Responsibilities:

Level 1 Review & QC

  • Perform initial (Level 1) content and technical review of ACTD/eCTD modules for completeness, accuracy, and consistency.

  • Conduct quality checks (QC) to ensure adherence to templates, style guides, and regional formatting requirements.

  • Highlight discrepancies, recommend corrections, and ensure proper document integration.

Document Authoring

  • Draft and format regulatory documents including CTD Modules (1 to3)

  • Collaborate with subject matter experts (SMEs) to accurately incorporate scientific and clinical data.

  • Maintain consistency across multiple documents in a submission package.

Regulatory Coordination

  • Assist in tracking document timelines and compiling components required for regulatory submissions.

  • Coordinate with publishing vendors and internal stakeholders to support final submission compilation.

  • Maintain document control and version management through regulatory document management systems.

Compliance & Continuous Learning

  • Ensure documents and review processes comply with internal SOPs and regional regulatory requirements.

  • Participate in regulatory training programs and keep up to date with evolving eCTD and biosimilar guidance.

  • Support audit readiness by organizing and maintaining submission-related documentation.

Qualifications:

  • M.Pharm, B.Pharm, or Life Sciences graduate with a strong interest in regulatory documentation.

  • 8-10 years of experience in regulatory affairs dossier compilation, preferably in the biosimilars or biologics domain.

  • Proficient in ACTD&eCTD/ requirements, and possess review skills.

  • High attention to detail with excellent written English and document formatting skills.

  • Strong interpersonal skills and ability to work collaboratively across teams.

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