I contribute to clinical research with expertise and empathy. And I do it
Senior Regulatory Affairs Associate
Primary Location: India, Bengaluru Job ID R0000037379 Category Regulatory Affairs Date Posted 12/09/2025Overview
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
About This Role
Key Accountabilities
Project Execution
- Works effectively in teams or independently within area of competence
- Works within project guidelines as directed by project/technical leads
- Prioritizes work to achieve project outcomes
- Seeks performance improvement and feedback
- Applies information from senior colleagues to complete assigned activities
- Produces quality work meeting project lead and client expectations
- May serve as Project Lead for small projects or Work Stream Lead on larger projects
- Functions as main client contact and ensures accurate project reporting
- Ensures team delivery meets client expectations for quality and timeliness
- Implements risk identification and issue-escalation procedures
- Ensures project-specific training compliance
- Manages project financials including revenue forecasts
- Ensures team works within contract scope
- Identifies new opportunities through Change In Scope or add-on business
- Ensures timely project close-out
Consulting Activities and Relationship Management
- Implements consulting models and methodologies under guidance
- Delivers services within personal expertise area
- Completes activities within project scope with understanding of profitability impacts
- Identifies issues and proposes solutions
- Interacts professionally at all levels within client organization and Parexel
- Identifies project/client needs and collaborates on solutions
- Maintains client satisfaction
- May assist with presentations with senior colleague support
- Identifies follow-on business opportunities or necessary scope changes
Regulatory Responsibilities
- Stay updated on local and regional regulatory requirements and guidelines
- Ensure compliance with evolving regulations
- Communicate requirements to GRA and local staff
- Participate in regulatory meetings, forums, and conferences
- Share insights and best practices within the organization
Dossier Management
- Review and submit dossiers
- Negotiate with Health Authorities on approvals
- Work with local Regulatory, Medical, Marketing, and Market Access teams to support impact of changes
Required Skills
- Project management knowledge
- Client-focused approach
- Results orientation
- Teamwork and collaboration
- Excellent interpersonal and intercultural communication
- Critical thinking and problem-solving
- Proficiency in local language and extensive English knowledge
Required Qualifications
- Bachelor's Degree in Scientific or Technical Discipline
- 4+ years of experience in an industry-related environment
Employee Insights
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