Senior Regulatory Affairs Associate - Clinical Trial Submissions

Parexel International (india) Private Limited; Bengaluru; Hybrid; INR 2,000,000 - 2,800,000; Full time

Job summary

Parexel International (india) Private Limited is seeking a Senior Regulatory Affairs Associate to lead end-to-end Clinical Trial Applications (CTA) across EU CTR and ROW regions from Bengaluru. The role requires strong regulatory expertise and global project management to ensure timely, compliant submissions.

Responsibilities include coordinating multi-country submissions, managing risks, and maintaining clinical/regulatory documentation while partnering with cross-functional teams for

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or related field.
• 5+ years of industry experience in pharmaceutical, CRO, or similar.
• Experience in Clinical Trial Application submissions (EU CTR & ROW).
• Strong project management experience in a global/matrix environment.
• Familiarity with clinical trials and regulatory processes.

Responsibilities

• Lead end-to-end CTA project management across multiple studies and countries.
• Plan, track, and deliver submissions aligned with timelines and regulatory requirements.
• Manage risks, dependencies, and complexities in global regulatory environments.
• Apply knowledge of EU CTR and ROW CTA requirements.
• Manage core clinical and regulatory documentation.
• Collaborate with cross-functional global teams.
• Build and maintain stakeholder relationships and resolve conflicts.
• Monitor KPIs related to timelines and deliverable quality.
• Identify risks and lead quality investigations as needed.

Skills

Project Management

Regulatory Knowledge

Risk & Issue Management

Stakeholder Engagement

Communication

Problem-solving

Teamwork

Education

Bachelor's degree in Life Sciences/Pharmacy or related field

Job description

Senior Regulatory Affairs Associate

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Summary:

The Clinical Trial Submission Lead (CTSL) is responsible for end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World (ROW) regions. This role ensures timely, high-quality, and compliant submissions through effective cross-functional collaboration, proactive risk management, and strong regulatory expertise.

Key Responsibilities:

• Lead end-to-end CTA project management across multiple studies and countries
• Plan, track, and deliver submissions aligned with timelines and regulatory requirements
• Manage risks, dependencies, and complexities in global regulatory environments
• Apply knowledge of EU CTR and ROW CTA requirements
• Manage core clinical and regulatory documentation
• Collaborate with cross-functional global teams
• Build and maintain stakeholder relationships and resolve conflicts
• Monitor KPIs related to timelines and deliverable quality
• Identify risks and lead quality investigations as needed

Qualifications & Experience:

• Bachelor's degree in Life Sciences, Pharmacy, or related field
• Minimum 5+ years of industry experience in pharmaceutical, CRO, or similar
• Experience in Clinical Trial Application submissions (EU CTR & ROW)
• Strong project management experience in a global/matrix environment
• Familiarity with clinical trials and regulatory processes

Key Skills:

• Project Management & Execution
• Regulatory Knowledge (EU CTR & Global Submissions)
• Risk & Issue Management
• Stakeholder Engagement
• Strong communication and problem-solving skills
• Adaptability, resilience, and teamwork

Experience Level:

Mid Level