Apply for Senior Regulatory Affairs Associate job at Parexel remote India. Check eligibility, responsibilities, salary, and regulatory career growth opportunities now.
Introduction
The Senior Regulatory Affairs Associate Job at Parexel is a high-growth opportunity for experienced professionals in regulatory affairs and pharmaceutical compliance. This role focuses on managing regulatory submissions, lifecycle activities, and global compliance strategies for drug products. If you have hands-on experience in regulatory CMC and post-approval processes, this remote position offers strong career advancement and international exposure.
Job Overview
| Job Details | Information |
|---|---|
| Job Title | Senior Regulatory Affairs Associate |
| Company Name | Parexel |
| Location | India (Remote) |
| Employment Type | Full-Time |
| Department | Regulatory Affairs / Consulting |
| Experience Required | 4–6 Years |
| Education | Bachelor’s Degree (Life Sciences/Pharma) |
| Salary | As per company norms |
Company Overview
Parexel is a globally recognized Clinical Research Organization (CRO) offering end-to-end services across clinical trials, regulatory consulting, and market access. The company partners with leading pharmaceutical and biotech firms to bring innovative treatments to market. Known for its collaborative work culture and focus on patient outcomes, Parexel provides professionals with opportunities to work on global regulatory projects.
Job Location & Employment Type
- Location: India (Work From Home)
- Employment Type: Full-Time
- Work Mode: Remote with global collaboration
Open Positions / Department Details
This role is part of the Regulatory Consulting team, focusing on lifecycle management and regulatory strategy for biologics and small molecule drugs. Candidates will work on global submissions and interact with multiple stakeholders across regions.
Key Roles & Responsibilities
The Senior Regulatory Affairs Associate Job at Parexel includes advanced regulatory and compliance responsibilities:
Regulatory Submissions & Strategy
- Prepare and manage regulatory maintenance submissions for global and regional markets
- Contribute to regulatory strategy and submission planning
- Support complex regulatory filings with increasing responsibility
CMC & Lifecycle Management
- Author and review CMC (Chemistry, Manufacturing & Controls) documentation
- Handle lifecycle management of approved products including biologics and small molecules
- Manage variations, renewals, and annual reports
Regulatory Compliance & Documentation
- Review DMFs, batch records, specifications, and stability data
- Ensure compliance with global regulatory standards and guidelines
- Prepare documentation for variation procedures like grouping and work-sharing
Health Authority Interaction
- Respond to regulatory queries from health authorities
- Provide impact assessments for change control activities
- Support GMP submissions and site registrations
Cross-Functional Collaboration
- Work closely with internal teams and global stakeholders
- Maintain submission plans and provide regular status updates
- Mentor junior team members and support team development
Labeling & Regulatory Systems
- Support labeling activities based on CCDS and regulatory recommendations
- Work with Regulatory Information Management Systems like Veeva Vault
- Ensure compliance with EU guidelines and global standards
Eligibility Criteria
Education
- Bachelor’s degree in Pharmacy, Life Sciences, or related field
Experience
- 4–6 years of experience in regulatory affairs
- Experience in lifecycle management of drug products
- Hands-on experience with biologics and small molecules preferred
Skills Required
- Strong knowledge of global regulatory frameworks (EU, US, ROW)
- Expertise in CMC documentation and regulatory submissions
- Familiarity with ICH guidelines and pharmaceutical regulations
- Experience with tools like Veeva Vault (RIMS)
- Excellent communication and stakeholder management skills
- Ability to work independently in a remote environment
- Leadership and mentoring abilities
- Strong analytical and problem-solving skills
Salary & Benefits
- Salary: As per company norms
- Additional benefits may include:
- Remote work flexibility
- Health and wellness benefits
- Performance-based incentives
- Learning and development programs
- Exposure to global regulatory projects
- Career growth in regulatory consulting
Selection Process
The hiring process generally includes:
- Application screening
- HR interview
- Technical interview
- Final discussion and offer
How to Apply
Interested candidates can apply for the Senior Regulatory Affairs Associate Job at Parexel through the official online application portal. Ensure your resume highlights regulatory experience, CMC expertise, and global submission knowledge.
Important Dates
- Application Deadline: Apply as soon as possible
Why Apply for This Job?
Here’s why this role stands out:
- Opportunity to work on global regulatory submissions
- Gain exposure to biologics, vaccines, and small molecules
- Work remotely with international teams
- Strong career growth in regulatory consulting
- Develop expertise in lifecycle management and compliance
- Be part of a globally respected CRO
This position is ideal for professionals looking to advance their regulatory affairs career and work on high-impact pharmaceutical projects.
FAQs
1. What is the role of a Senior Regulatory Affairs Associate?
The role involves managing regulatory submissions, lifecycle activities, and compliance for pharmaceutical products.
2. What experience is required for this job?
Candidates need 4–6 years of regulatory affairs experience, especially in CMC and lifecycle management.
3. Is this a remote job?
Yes, this position offers work-from-home flexibility across India.
4. What skills are essential for this role?
Key skills include regulatory knowledge, CMC expertise, communication, and project management.
5. How can I apply for this job?
You can apply through Parexel’s official online application portal.
Conclusion
The Senior Regulatory Affairs Associate Job at Parexel 2026 is an excellent opportunity for experienced professionals aiming to grow in global regulatory affairs. With exposure to international markets, advanced regulatory processes, and flexible work options, this role can significantly enhance your career. Apply now to take the next step in your professional journey.
Disclaimer
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