Senior Regulatory Affairs Associate Jobs

Parexel

Location:
India, Bengaluru

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

Job Responsibility:

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
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
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
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

Requirements:

Bachelor's Degree in Scientific or Technical Discipline
4+ years of experience in an industry-related environment
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

What we offer:

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Additional Information:

Job Posted:
December 11, 2025

Work Type:

Remote work

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Senior Regulatory Affairs Associate