Parexel Recruitment 2026: Senior Regulatory Affairs Associate (Clinical Trial Application) | Work from Home / Remote
Pharm'Up 
Parexel Consulting, a global contract research organization (CRO) and biopharmaceutical services leader, is inviting applications from experienced regulatory professionals for the remote position of Senior Regulatory Affairs Associate – Clinical Trial Application (Clinical Trial Submission Lead / CTSL).
Position Overview
- Job Title: Senior Regulatory Affairs Associate – Clinical Trial Application
- Functional Role: Clinical Trial Submission Lead (CTSL)
- Job ID: R0000044936
- Category: Regulatory / Consulting
- Work Location: India (100% Remote / Work from Home)
- Posted Date: September 15, 2026
Role & Key Responsibilities
The Clinical Trial Submission Lead (CTSL) will oversee end-to-end regulatory planning, coordination, and dossier submissions for clinical trials across diverse geographies:
- End-to-End Submission Management: Lead, track, and execute Clinical Trial Applications (CTA) across the European Union (EU CTR) and Rest of the World (ROW) markets.
- Regulatory Compliance & Delivery: Ensure submissions strictly comply with regional health authority guidelines, statutory timelines, and project milestones.
- Cross-Functional Leadership: Coordinate with global study teams, cross-functional clinical specialists, and client stakeholders to resolve submission dependencies and operational bottlenecks.
- Dossier & Document Oversight: Manage core clinical and regulatory documentation, monitor key performance indicators (KPIs) for submission quality, and lead regulatory risk mitigation or quality reviews as necessary.
Eligibility Criteria & Key Skills
Educational Qualification & Experience
- Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or an equivalent discipline.
- Experience: Minimum 5+ years of hands-on regulatory experience within a CRO, pharmaceutical company, or biotech environment.
- Domain Expertise: Proven track record in handling Clinical Trial Application (CTA) submissions under EU CTR regulations and global ROW country guidelines.
Key Competencies
- Strong regulatory project management in a global, matrix team setting.
- In-depth understanding of the global clinical trial lifecycle and regional health authority frameworks.
- Proactive stakeholder management, risk evaluation, and issue resolution capabilities.
- Exceptional written and verbal communication, adaptability, and cross-functional team skills.
How to Apply
Interested candidates can apply directly through the Parexel Careers portal by referencing Job ID: R0000044936.
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