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パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。

Senior Regulatory Affairs Associate

求人ID R0000037379 ロケーション バンガロール, カルナータカ州 仕事内容

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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