I contribute to clinical research with expertise and empathy. And I do it

Search Jobs

Search Jobs

Keyword Matching job links will appear below as you type.

Location: When autocomplete results are available use up and down arrows to review and enter to select. Touch device users, explore by touch or with swipe gestures.

Radius: Enter distance 5 15 25 35 50

Unit MILES KM

View Remote Jobs View All Jobs

View remote jobs View all jobs

Senior Regulatory Affairs Associate- Clinical Trial Application

Primary Location: India, Remote Job ID R0000044936 Category Regulatory / Consulting Date Posted 09/09/2026

Apply Now

- Success profile
- About this role
- Employee insights
- Why Consultants work at Parexel
- Learn about our culture

Overview As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there. We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic

Back to nav About This Role About Parexel Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

About The Role We are seeking a Clinical Trial Submission Lead to join our team in a remote capacity. As a Clinical Trial Submission Lead, you will drive end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World regions.

This position plays a critical role in ensuring timely, high-quality, and compliant submissions that advance new treatments for patients. You will leverage regulatory expertise, cross-functional collaboration, and proactive risk management to navigate complex global regulatory environments and deliver exceptional results.

You will collaborate with global teams, manage clinical and regulatory documentation,



and contribute to study operations from planning through submission closeout. This role offers opportunities to deepen your expertise in regulatory submissions, expand your influence across international markets, and shape the future of clinical trial delivery.

You will join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic regulatory leadership and operational excellence. With diverse teams and continuous learning opportunities, the Clinical Trial Submission Lead can explore career paths and expand skills across clinical research and regulatory affairs.

Key Responsibilities

- Lead end-to-end Clinical Trial Application project management across multiple studies and countries, ensuring alignment with timelines and regulatory requirements
- Plan, track, and deliver submissions across EU CTR and Rest of the World regions with meticulous attention to compliance and quality standards
- Manage risks, dependencies, and complexities in global regulatory environments through proactive identification and mitigation strategies
- Apply deep knowledge of EU CTR and ROW CTA requirements to ensure submissions meet all regulatory expectations
- Manage core clinical and regulatory documentation, maintaining accuracy and completeness throughout the submission lifecycle
- Collaborate with cross-functional global teams including clinical, regulatory, and operations to coordinate seamless submission execution
- Build and maintain strong stakeholder relationships across internal and external partners, resolving conflicts and ensuring alignment
- Monitor key performance indicators related to submission timelines and deliverable quality, driving continuous improvement
- Identify emerging risks and lead quality investigations as needed to maintain submission integrity

You Will Thrive In This Role If You Bring

- Strengths in project management, regulatory knowledge, and stakeholder engagement
- Experience working in clinical research, pharmaceutical, or CRO environments
- The ability to collaborate across global teams and communicate clearly with diverse audiences
- A patient-focused mindset and strong attention to detail in regulatory submissions
- Comfort working with clinical trial management systems and regulatory documentation platforms

Required Qualifications

- Bachelor's degree in Life Sciences, Pharmacy, or related field
- Minimum 5+ years of industry experience in pharmaceutical, CRO, or similar regulated environments
- Demonstrated experience in Clinical Trial Application submissions (EU CTR and Rest of the World)
- Strong project management experience in global and matrix environments
- Knowledge of clinical trial processes and regulatory requirements
- Solid communication, organization, and problem-solving skills

Preferred Qualifications

- Advanced degree or professional certification in regulatory affairs or clinical research




- Experience with regulatory submission systems and electronic trial master files (eTMF)
- Familiarity with ICH-GCP guidelines and international regulatory pathways
- Experience managing submissions across multiple therapeutic areas or study phases

Back to nav

Share this job

- LinkedIn
- Facebook
- X
- Email

Employee Insights How to describe Parexel culture in one word

Insights from Parexel employees

Watch Video

Jo on diverse project work and team culture

Jo Wang | Vice President, Technical

Watch Video

Kurt on colleagues and growth opportunities

Kurt Brorson | Vice President, Technical

Watch Video

Back to nav

Why Consultants work at Parexel

Patient-led in everything we do

We are inspired by the patients behind the data and therefore deliver first-time quality and on-time projects.

Supportive and inclusive environment

We thrive on collaboration, caring, and inclusivity - enabling our people to work together to solve complex problems and share knowledge.

Opportunities for growth opportunities

We provide a wide range of challenging assignments, product types, geographic regions, and therapeutic areas, providing ample opportunities for learning and growth.

Flexible work arrangements

We offer the flexibility of remote work, allowing you to balance your personal and professional responsibilities while still contributing to our “We Care” team environment.

Diverse and global client exposure

We continuously learn by working with a global network of colleagues and clients to develop regulatory strategies to support their product development and approval.

Learn from experts

You will work with a team of highly experienced regulatory professionals who can serve as mentors, providing guidance and support as you develop your skills and advance in your career.

Back to nav

Learn About Our Culture

Back to nav

Back to nav

- Meet Muskaan Oberoi, a Patient Safety Associate II at Parexel

Muskaan brings dedication, teamwork, and a passion for innovation to her role. Discover her journey, daily impact, and what keeps her motivated to grow, With Heart®.

Learn More

- Re-excel at Parexel: A Return-to-Work Program for Professionals

Parexel's Re-Excel program is designed to help professionals restart their careers after a break, providing structured support, skill-building opportunities, and a welcoming community.

Learn More

- Meet Sanjay: India Country Head & Head CTS&L;

Sanjay discusses his dual role, Parexel’s strong collaborative and cohesive working environment, and how our patient-centric culture makes him feel connected.

Learn More

- Inclusion at Parexel

Learn how Parexel celebrates the differences our workforce and patients bring and ensures an inclusive environment.

Learn More

- Emerging Talent Opportunities

Begin your career journey at Parexel with our emerging talent programs or our internships, placements and entry-level clinical roles. Advance science by keeping the patients in mind.

Learn More

- Benefits & Support

At Parexel, we prioritize putting people first, allowing you to achieve your best work. Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture.

Learn More

📌 Senior Regulatory Affairs Associate- Clinical Trial Application (India)
🏢 ATLAS MEDICAL SERVICES LTD. STI.
📍 India