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Parexel is hiring a Senior Regulatory Affairs Associate to join its growing team in Bengaluru. At Parexel, our mission is to improve the world’s health by supporting the development of therapies that make a real difference in patients’ lives. Every role contributes directly to global clinical development and regulatory success.
Location: Bengaluru, Karnataka, India
Experience Required: 4+ Years
Qualification: Bachelor’s Degree (Scientific / Technical Discipline)
Job ID: R0000037379
Posted: 23 Days Ago
Key Responsibilities
Project Execution
- Work independently or within cross-functional teams to deliver regulatory projects
- Execute activities as per project guidelines under project/technical leads
- Prioritize tasks to meet project timelines and quality standards
- Act as Project Lead for small projects or Work Stream Lead on larger engagements
- Serve as a key client contact and ensure accurate project reporting
- Manage project financials, scope, risks, and timely project close-out
Consulting & Client Relationship Management
- Support consulting models and methodologies under guidance
- Deliver services within scope while ensuring client satisfaction
- Identify issues, propose solutions, and support follow-on business opportunities
- Collaborate effectively with internal teams and client stakeholders
Regulatory Affairs Responsibilities
- Stay updated on local and regional regulatory requirements
- Ensure compliance with evolving regulatory guidelines
- Communicate regulatory updates to global and local teams
- Participate in regulatory meetings, forums, and knowledge-sharing initiatives
Dossier Management
- Review, prepare, and submit regulatory dossiers
- Interact and negotiate with Health Authorities for approvals
- Coordinate with Regulatory, Medical, Marketing, and Market Access teams
Required Skills
- Strong project management capabilities
- Client-focused and results-driven mindset
- Excellent teamwork and collaboration skills
- Critical thinking and problem-solving abilities
- Strong interpersonal and intercultural communication
- Proficiency in English and local language
🎓 Qualifications & Experience
- Bachelor’s Degree in a Scientific or Technical discipline
- Minimum 4+ years of experience in an industry-related regulatory environment
Why Join Parexel?
- Work on global projects that impact patient lives
- Collaborative, value-driven work culture
- Opportunity to grow within regulatory consulting and clinical development
📌 Apply now and be part of a team where your work truly makes a difference.
