Parexel is hiring for the position of Senior Regulatory Affairs Associate – Clinical Trial Application in India. The role is listed as a remote opportunity and is part of Parexel Consulting, where professionals support biopharmaceutical and medical device organizations with regulatory strategy and clinical development activities.
The position focuses on the end-to-end planning, coordination, and execution of Clinical Trial Application (CTA) submissions across the European Union Clinical Trials Regulation (EU CTR) and Rest of the World (ROW) regions.
This opportunity is intended for experienced regulatory professionals with a Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline and at least 5 years of relevant industry experience in pharmaceutical, CRO, or similar organizations.
Parexel Recruitment 2026 – Job Highlights
| Particulars | Details |
|---|---|
| Company | Parexel |
| Job Title | Senior Regulatory Affairs Associate – Clinical Trial Application |
| Functional Role | Clinical Trial Submission Lead (CTSL) |
| Job Location | India – Remote |
| Employment Type | Not specified in the provided details |
| Experience | 5+ years |
| Education | Bachelor’s degree in Life Sciences, Pharmacy, or related field |
| Industry | Pharmaceutical / CRO / Clinical Research |
| Key Area | Clinical Trial Applications / Regulatory Affairs |
| Regions | EU CTR and Rest of World (ROW) |
| Work Mode | Remote |
| Salary / CTC | Not specified |
| Application Mode | Online |
About Parexel Consulting
Parexel Consulting works with biopharmaceutical and medical device organizations on regulatory and clinical development challenges. The consulting environment provides exposure to different product types, therapeutic areas, clients, and regulatory requirements.
In this position, the selected professional will work with global teams and clients on regulatory submissions while applying regulatory knowledge, project management capabilities, and risk-management practices.
Job Description
The Senior Regulatory Affairs Associate – Clinical Trial Application will serve as a Clinical Trial Submission Lead (CTSL), responsible for planning, coordinating, and executing Clinical Trial Applications across multiple countries and regions.
The role requires close collaboration with regulatory, clinical, and other cross-functional teams to ensure that submissions are prepared and delivered according to applicable regulatory requirements and agreed timelines.
The position also involves monitoring submission progress, managing dependencies and risks, maintaining stakeholder relationships, and supporting quality investigations when required.
Clinical Trial Submission Lead
The CTSL will oversee CTA activities across multiple studies and countries, coordinating regulatory deliverables and helping project teams navigate complex global submission requirements.
Educational Qualification
Candidates should have:
- Bachelor’s degree in Life Sciences
- Bachelor’s degree in Pharmacy
- Bachelor’s degree in a related scientific or relevant field
The educational background should support the candidate’s experience in clinical research and regulatory affairs.
Experience Requirements
Candidates should have a minimum of 5+ years of industry experience in one or more relevant environments, such as:
- Pharmaceutical companies
- Contract Research Organizations (CROs)
- Clinical research organizations
- Related life sciences or regulatory environments
Relevant experience should include exposure to Clinical Trial Application submissions, particularly across EU CTR and ROW regions.
Regulatory Affairs Knowledge
The role requires practical knowledge of:
- Clinical Trial Applications
- EU CTR requirements
- Rest of the World CTA submissions
- Global regulatory submissions
- Clinical trial processes
- Regulatory documentation
- Regulatory procedures and requirements
- Submission planning and execution
Candidates should be comfortable working with regulatory requirements across multiple countries and navigating differences in global regulatory environments.
Key Responsibilities
1. End-to-End CTA Project Management
The selected candidate will:
- Lead Clinical Trial Application activities across multiple studies and countries.
- Plan submission activities according to project timelines.
- Coordinate regulatory deliverables from planning through submission.
- Track submission milestones and deliverables.
- Ensure activities remain aligned with applicable regulatory requirements.
- Manage multiple CTA projects as required.
2. Global Regulatory Submission Management
Responsibilities include:
- Apply knowledge of EU CTR requirements.
- Support and manage ROW CTA submissions.
- Coordinate global regulatory filing activities.
- Maintain awareness of country-specific regulatory requirements.
- Address complexities arising from different regulatory environments.
- Support compliant and timely submission execution.
3. Regulatory Documentation
The role involves managing core clinical and regulatory documentation, including:
- Coordinating required submission documents.
- Tracking document readiness and deliverables.
- Ensuring appropriate documentation is available for submissions.
- Supporting high-quality regulatory filing packages.
- Maintaining documentation according to applicable processes.
4. Timeline and Deliverable Management
The CTSL will be responsible for monitoring project progress by:
- Establishing and tracking submission timelines.
- Monitoring deliverable completion.
- Identifying potential delays.
- Managing dependencies between project activities.
- Escalating relevant risks when required.
- Monitoring the quality and timeliness of deliverables.
5. Risk and Issue Management
The position requires proactive management of project risks and issues.
The selected candidate may:
- Identify risks associated with regulatory submissions.
- Evaluate project dependencies and potential obstacles.
- Support mitigation planning.
- Lead quality investigations when required.
- Monitor issues through resolution.
- Communicate significant risks to relevant stakeholders.
6. Cross-Functional Collaboration
The role requires collaboration with global and cross-functional teams.
Responsibilities include:
- Working with regulatory and clinical stakeholders.
- Coordinating activities across global teams.
- Supporting alignment between different functions.
- Resolving project-related conflicts.
- Maintaining effective communication throughout submission activities.
7. Stakeholder and Client Management
The position involves developing and maintaining professional relationships with stakeholders.
This includes:
- Building productive stakeholder relationships.
- Understanding project requirements.
- Communicating submission status and risks.
- Resolving conflicts constructively.
- Maintaining clear and professional communication with clients and internal teams.
8. KPI and Quality Monitoring
The selected candidate will monitor key performance indicators associated with:
- Regulatory submission timelines
- Deliverable completion
- Submission quality
- Project execution
- Identified risks and issues
The role may also involve supporting quality investigations when required.
Project Management Skills
Strong project management capabilities are important for this position.
Candidates should be able to:
- Plan complex regulatory activities.
- Manage multiple timelines and deliverables.
- Track dependencies.
- Prioritize competing requirements.
- Identify potential project risks.
- Coordinate activities across global teams.
- Drive assigned projects toward agreed objectives.
Experience working within a global or matrix organization is specifically mentioned in the vacancy.
Required Skills
Candidates should demonstrate the following capabilities:
Regulatory and Technical Skills
- Clinical Trial Application knowledge
- EU CTR regulatory knowledge
- Global/ROW submission experience
- Understanding of clinical trial processes
- Regulatory documentation management
- Regulatory process knowledge
Project and Risk Management
- Project planning and execution
- Timeline management
- Risk and issue management
- Dependency management
- Quality investigation support
- KPI monitoring
Communication and Collaboration
- Strong written and verbal communication
- Stakeholder engagement
- Relationship-building
- Conflict resolution
- Team collaboration
- Client-focused communication
- Presentation and coordination skills
Personal and Professional Attributes
The Parexel success profile highlights qualities such as:
- Detail orientation
- Problem-solving
- Results-driven approach
- Strategic thinking
- Adaptability
- Resilience
- Effective communication
- Relationship building
Work Location and Work Mode
Location: India – Remote
The position is described as a remote opportunity. The provided vacancy information does not specify fixed working hours or shift timings.
Candidates should confirm any role-specific work schedule or other employment conditions during the recruitment process.
Salary / CTC
The salary or CTC for this position has not been specified in the available vacancy details.
Candidates should confirm the compensation package directly with Parexel during the recruitment process.
Career and Professional Exposure
As part of Parexel Consulting, the role can involve working with different clients, product types, therapeutic areas, and regulatory environments.
The vacancy also highlights opportunities to develop regulatory expertise through challenging assignments, collaboration with experienced professionals, and mentorship.
These opportunities depend on project assignments and business requirements.
Selection Process
A detailed selection process has not been provided in the vacancy information.
Candidates may be assessed on their:
- Clinical Trial Application experience
- EU CTR and ROW regulatory knowledge
- Project management capabilities
- Risk and issue management experience
- Communication and stakeholder-management skills
- Experience working in global or matrix environments
The exact recruitment stages should be confirmed through Parexel’s hiring process.
How to Apply for Parexel Recruitment 2026
Interested and eligible candidates can apply online through the official Parexel recruitment portal.
Candidates should provide accurate details regarding their education, regulatory affairs experience, Clinical Trial Application experience, and relevant project-management background.
Important Details Before Applying
- The position is Senior Regulatory Affairs Associate – Clinical Trial Application.
- The functional role is described as Clinical Trial Submission Lead (CTSL).
- The position is listed as India – Remote.
- A Bachelor’s degree in Life Sciences, Pharmacy, or a related field is required.
- Minimum 5+ years of industry experience is specified.
- Experience with EU CTR and ROW Clinical Trial Applications is required.
- Global or matrix project-management experience is important.
- Knowledge of clinical trials and regulatory processes is required.
- Strong stakeholder-management and communication skills are expected.
- Salary/CTC is not disclosed in the provided vacancy.
- Candidates should verify the latest job status and requirements before submitting an application.
Frequently Asked Questions
1. What is the job title at Parexel?
The position is Senior Regulatory Affairs Associate – Clinical Trial Application.
2. What is the functional role for this position?
The job description identifies the functional role as Clinical Trial Submission Lead (CTSL).
3. Where is the position located?
The job is listed as India – Remote.
4. What educational qualification is required?
Candidates should have a Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
5. How much experience is required?
The vacancy specifies a minimum of 5+ years of industry experience in pharmaceutical, CRO, or similar environments.
6. What type of regulatory experience is required?
Experience with Clinical Trial Application submissions across EU CTR and Rest of the World (ROW) regions is required.
7. Is project management experience necessary?
Yes. The vacancy specifically highlights strong project management experience in a global or matrix environment.
8. What are the major responsibilities?
The major responsibilities include CTA planning and execution, regulatory documentation management, timeline tracking, risk and issue management, stakeholder coordination, KPI monitoring, and quality investigation support.
9. Is the job remote?
Yes. The listed primary location is India, Remote.
10. Is salary information available?
No. The salary/CTC has not been specified in the provided job information.
Important Note
Job requirements, vacancy status, recruitment timelines, compensation, work arrangements, and employment conditions may change. Candidates should verify the latest information on the official Parexel recruitment portal before applying. Submitting an application does not guarantee selection or employment.