Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Regulatory Affairs Associate
Job ID R0000037379 Bengaluru, Karnataka, IndiaKey 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
Recently Viewed Jobs
You have not recently viewed any jobs
View all jobs