India's DMPLOI - Jobs & Networking App
Parexel
Company: Parexel
Job Title: Senior Regulatory Affairs Associate – Clinical Trial Application
Location: Serilingampalli, Telangana, India
Work Mode: Remote
Job ID: R0000044936
Department: Regulatory Affairs / Clinical Trial Submissions
Industry: Clinical Research / CRO
Experience: Minimum 5+ years
Qualification: Bachelor’s degree in Pharmacy, Life Sciences, or a related field
Job Type: Full-time (confirm on the official listing)
About Parexel
Parexel is a leading global clinical research organization (CRO) providing clinical development and consulting services to the life sciences industry. The company partners with biopharmaceutical organizations and research sites to advance clinical trials and help bring new treatments to patients.
Job Overview
Parexel is seeking an experienced regulatory professional to support and lead Clinical Trial Application (CTA) submissions across the European Union Clinical Trials Regulation (EU CTR) and Rest of the World (ROW) regions.
The selected candidate will coordinate end-to-end submission planning, manage regulatory documentation, collaborate with global cross-functional teams, and ensure submissions meet regulatory requirements, quality standards, and project timelines.
This remote opportunity is suitable for professionals with strong clinical trial submission expertise and experience working in pharmaceutical companies, CROs, or other regulated environments.
Key Responsibilities
- Lead end-to-end Clinical Trial Application project management across multiple studies and countries.
- Plan, coordinate, track, and deliver submissions across EU CTR and ROW regions.
- Ensure regulatory compliance, submission quality, and adherence to timelines.
- Identify and mitigate submission risks, dependencies, and potential delays.
- Manage clinical and regulatory documentation throughout the submission lifecycle.
- Collaborate with global clinical, regulatory, and operational teams.
- Maintain effective relationships with internal and external stakeholders.
- Monitor submission timelines, performance indicators, and deliverable quality.
- Lead quality investigations and implement corrective measures when required.
Required Qualifications and Skills
- Bachelor’s degree in Pharmacy, Life Sciences, or a related discipline.
- Minimum 5+ years of relevant industry experience.
- Demonstrated experience in Clinical Trial Application submissions.
- Knowledge of EU CTR and Rest of the World regulatory requirements.
- Strong project management skills in global, cross-functional environments.
- Understanding of clinical trial processes and regulatory documentation.
- Excellent communication, organizational, and problem-solving abilities.
- Familiarity with clinical trial management systems and regulatory documentation platforms.
Why Consider This Opportunity?
- Remote work opportunity in regulatory affairs.
- Exposure to global clinical trial submissions.
- Collaboration with international clinical research teams.
- Opportunities to develop regulatory project management expertise.
- Contribution to clinical research and the development of new treatments.
How to Apply
Interested and eligible candidates can review the complete job description and submit their applications through the official Parexel careers listing.
Official Job Application:
https://www.linkedin.com/jobs/view/4470086171/
To apply for this job please visit jobs.parexel.com.
