Senior Regulatory Affairs Associate - Clinical Trial Submissions

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

• It is a Full Time Legal job for candidates with 5 - 6+ years Experience.

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Who is eligible to apply for this Senior Regulatory Affairs Associate - Clinical Trial Submissions job at Parexel International (india) Private Limited?

Ans : Candidates should have All Education levels for this Senior Regulatory Affairs Associate - Clinical Trial Submissions job offered by Parexel International (india) Private Limited.

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Ans : Salary details will be shared during the hiring process.

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Ans : This Senior Regulatory Affairs Associate - Clinical Trial Submissions job follows a Day shift.

Do you need to visit the office for this job?

Ans : Yes, candidates need to visit the office and work from the location in Malur, Bangalore.

How many openings are available for this position?

Ans : There is 1 opening available for this position.

Is this job open for all genders?

Ans : Yes, this Senior Regulatory Affairs Associate - Clinical Trial Submissions job is open for both male and female candidates.

Where is this job located?

Ans : This Senior Regulatory Affairs Associate - Clinical Trial Submissions job is located in Malur, Bangalore.

Why should you apply for this Senior Regulatory Affairs Associate - Clinical Trial Submissions job?

Ans : The employer has not disclosed the salary for this role, but it is a Full Time opportunity with 1 opening available.