Senior Regulatory Affairs Associate job at Parexel Bengaluru remote. Check eligibility, experience, responsibilities, and apply online for regulatory role today now.
Introduction
If you have experience in regulatory affairs and want to work on global submissions and lifecycle management, this opportunity is highly rewarding. The Senior Regulatory Affairs Associate Job at Parexel offers exposure to international regulatory strategies, dossier management, and cross-functional collaboration.
This role is ideal for professionals looking to advance their careers in regulatory affairs while working with global clients in a flexible, hybrid or remote setup.
Job Overview
| Details | Information |
|---|---|
| Job Title | Senior Regulatory Affairs Associate |
| Company Name | Parexel |
| Location | Bengaluru, India / Remote |
| Employment Type | Full-time |
| Department | Regulatory Affairs / Consulting |
| Experience Required | Mid-level (Relevant experience required) |
| Education | Life Sciences / Pharmacy / Related Fields |
| Salary | As per company standards |
Company Overview
Parexel is a leading global CRO offering clinical research, regulatory consulting, and market access services. The company partners with pharmaceutical and biotech organizations to accelerate drug development and ensure regulatory compliance worldwide.
Parexel is known for its collaborative culture, strong regulatory expertise, and flexible work environment, making it a preferred choice for professionals in regulatory affairs.
Job Location & Employment Type
- Location: Bengaluru, India (Remote option available)
- Employment Type: Full-time
- Work Mode: Hybrid / Remote flexibility
Open Positions / Department Details
- Role: Senior Regulatory Affairs Associate
- Department: Regulatory Affairs / Consulting
- Focus on regulatory lifecycle management, submissions, and compliance.
Key Roles & Responsibilities
As a Senior Regulatory Affairs Associate, your responsibilities will include:
Regulatory Documentation & Submissions
- Preparing and reviewing country-specific regulatory documents (Module 1, forms, templates)
- Supporting submissions such as:
- New registrations
- Renewals
- Variations
- PSUR/PBRER safety reports
- Label updates and CMC changes
Lifecycle Management
- Managing post-approval changes and regulatory updates
- Tracking submission timelines and ensuring compliance
- Maintaining regulatory databases (e.g., Veeva RIMS)
Change Control & Strategy
- Evaluating change control notifications and regulatory impact
- Supporting implementation of manufacturing, safety, and labeling changes
- Coordinating with global and regional regulatory teams
Compliance & Audit Support
- Supporting audits and health authority inspections
- Preparing documentation for regulatory inspections
- Assisting in CAPA (Corrective and Preventive Actions) closure
Cross-Functional Collaboration
- Working with Quality, Supply Chain, Pharmacovigilance, and Medical teams
- Ensuring alignment between global and local regulatory requirements
Eligibility Criteria
Education
Candidates must have a degree in:
- Pharmacy (B.Pharm / M.Pharm)
- Life Sciences
- Biotechnology or related fields
Experience
- Relevant experience in regulatory affairs (mid-level role)
- Experience in lifecycle management and submissions preferred
Skills Required
- Strong knowledge of CTD/eCTD structure (especially Module 1)
- Experience in regulatory submissions and lifecycle management
- Understanding of global regulatory guidelines
- Excellent documentation and attention to detail
- Strong communication and coordination skills
- Familiarity with regulatory databases (e.g., Veeva RIMS)
Salary & Benefits
- Salary: As per company standards
- Hybrid/remote work flexibility
- Exposure to global regulatory projects
- Career growth in regulatory consulting
- Learning and development opportunities
- Collaborative and inclusive work culture
Selection Process
The hiring process may include:
- Resume screening
- Technical/regulatory interview
- HR discussion
- Final selection
How to Apply
- Candidates should apply through the official Parexel careers portal.
- Ensure your CV highlights regulatory submissions and lifecycle management experience.
Important Dates
- Last date to apply: Not specified
Why Apply for This Job?
The Senior Regulatory Affairs Associate Job at Parexel is an excellent opportunity for professionals aiming to grow in regulatory consulting and global submissions.
Here’s why this role stands out:
- Work on international regulatory projects
- Gain expertise in lifecycle management and compliance
- Flexible remote working options
- Opportunity to grow into:
- Regulatory Affairs Manager
- Regulatory Consultant
- Global Submission Specialist
- Compliance Lead
FAQs
1. Who can apply for this job?
Candidates with Pharmacy or Life Sciences backgrounds and regulatory experience can apply.
2. Is this a remote job?
Yes, the role offers hybrid and remote work options.
3. What is the required experience?
Mid-level experience in regulatory affairs is required.
4. What skills are important for this role?
Regulatory documentation, CTD knowledge, lifecycle management, and communication skills.
5. How can I apply?
You can apply through the official Parexel careers website.
Conclusion
The Senior Regulatory Affairs Associate Job at Parexel is a strong career opportunity for professionals in regulatory affairs looking to work on global projects with flexible working options. With exposure to international submissions and compliance strategies, this role offers excellent long-term growth.
If you have relevant experience and want to advance in regulatory consulting, apply now.
Disclaimer
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