Senior Regulatory Affairs Associate
Primary Location: India, Bengaluru 求人ID R0000037379 Category Regulatory / ConsultingAbout 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
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