Latest pharma jobs Senior Regulatory Affairs Associate Parexel job for freshers and experienced candidates apply online eligibility salary details
Introduction
If you are an experienced regulatory professional looking to advance your career in global submissions and compliance, this opportunity is worth exploring. The Senior Regulatory Affairs Associate Parexel Job 2026 offers a strategic role where you will work on international regulatory projects, particularly focusing on US and Canada submissions. This position is ideal for professionals with strong regulatory knowledge who want to work remotely while contributing to global pharmaceutical development.
Job Overview
| Details | Information |
|---|---|
| Job Title | Senior Regulatory Affairs Associate |
| Company Name | Parexel |
| Location | Remote (India) |
| Employment Type | Full-Time |
| Department | Regulatory Affairs / Consulting |
| Experience Required | 5+ Years |
| Education | Life Sciences / Pharmacy / Related Field |
| Salary | As per company norms |
Company Overview
Parexel is a leading contract research organization (CRO) that provides consulting, clinical development, regulatory, and market access services to pharmaceutical and biotechnology companies. The organization helps clients navigate complex regulatory pathways and bring innovative therapies to market efficiently.
Parexel Consulting is known for its expertise in global regulatory strategy, offering professionals the opportunity to work across multiple therapeutic areas and product types.
Job Location & Employment Type
This is a remote job opportunity in India, allowing flexibility to work from home. It is a full-time position with exposure to global regulatory submissions and consulting projects.
Open Positions / Department Details
The role is part of the Regulatory Affairs Consulting team, focusing on regulatory strategy and submissions for pharmaceutical products.
Key areas include:
- Regulatory submissions (US & Canada)
- CMC documentation and compliance
- Regulatory strategy development
- Global submission coordination
Key Roles & Responsibilities
As part of the Senior Regulatory Affairs Associate Parexel Job, your responsibilities will include:
Regulatory Submission & Documentation
- Preparing and managing CMC submission content plans (SCP)
- Authoring Module 1 documents for regulatory submissions
- Compiling annual regulatory reports and tracking changes
- Managing up to 20–40 reportable changes depending on complexity
Coordination & Strategy
- Collaborating with internal teams and stakeholders for data collection
- Supporting regulatory strategy alignment for submissions
- Coordinating with Regulatory Operations for publishing and dispatch
- Following up with country regulatory teams on submission status
Regulatory Compliance
- Ensuring compliance with US and Canada regulatory requirements
- Maintaining accurate documentation in regulatory systems (RIM)
- Managing regulatory events and closing submission activities
- Supporting audit readiness and regulatory inspections
Eligibility Criteria
Education
- Degree in:
- Pharmacy
- Life Sciences
- Biotechnology
- Related discipline
Experience
- Minimum 5+ years of experience in:
- Regulatory Affairs (Pharmaceutical industry)
- Experience with US and Canada submissions is required
Skills Required
- Strong knowledge of regulatory guidelines and submission processes
- Experience in CMC documentation and Module 1 authoring
- Ability to manage multiple projects and deadlines
- Strong communication and stakeholder management skills
- Attention to detail and compliance-focused mindset
- Problem-solving and strategic thinking ability
Salary & Benefits
Salary: As per company norms
Benefits include:
- Remote work flexibility
- Opportunity to work on global regulatory projects
- Exposure to US and Canada regulatory systems
- Career growth in regulatory consulting
- Learning and development programs
- Collaborative and supportive work environment
Selection Process
The hiring process for the Senior Regulatory Affairs Associate Parexel Job typically includes:
- Resume screening
- Technical/regulatory interview
- HR discussion
- Final selection
How to Apply
Interested candidates can apply through the online application process:
- Visit the official careers page of Parexel
- Search for the role: Senior Regulatory Affairs Associate
- Fill in the application form
- Upload your updated resume
- Submit your application
Apply early to increase your chances of selection.
Important Dates
- Last Date to Apply: Not specified
Why Apply for This Job?
The Senior Regulatory Affairs Associate Parexel Job 2026 offers excellent career benefits:
- Work on international regulatory submissions (US & Canada)
- Gain experience in regulatory strategy and consulting
- Remote work flexibility with global exposure
- Opportunity to handle complex regulatory projects
- Strong career growth in regulatory affairs domain
- Work with a reputed global CRO organization
This role is ideal for professionals aiming to grow in regulatory affairs, global submissions, or regulatory consulting.
FAQs
1. What is the focus keyword for this job?
The focus keyword is Senior Regulatory Affairs Associate Parexel Job.
2. What experience is required for this role?
Candidates need at least 5 years of experience in regulatory affairs, especially in pharmaceutical submissions.
3. Is this a remote job?
Yes, this is a fully remote role based in India.
4. What regions are covered in this role?
The role focuses on US and Canada regulatory submissions.
5. What skills are essential for this job?
Regulatory knowledge, CMC documentation, Module 1 authoring, and project management skills are essential.
Conclusion
The Senior Regulatory Affairs Associate Parexel Job 2026 is a strong opportunity for experienced professionals in regulatory affairs. With global exposure, remote flexibility, and involvement in complex submissions, this role offers excellent career advancement. Interested candidates should apply online as soon as possible.
Disclaimer
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