Senior Regulatory Affairs Associate

Year    KA, IN, India

Job Description

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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Job Detail

  • Job Id
    JD4903707
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    KA, IN, India
  • Education
    Not mentioned
  • Experience
    Year