Senior Regulatory Affairs Associate

Senior Regulatory Affairs Associate

This role offers the opportunity to lead the planning, coordination, and execution of clinical trial submissions across multiple countries and regulatory environments. You will manage Clinical Trial Applications (CTAs) from end to end, ensuring submissions are timely, accurate, and compliant. Working across EU CTR and Rest of World (ROW) requirements, you will navigate complex regulatory landscapes and proactively manage risks and dependencies. The position involves close collaboration with global clinical, regulatory, and operational teams. You will also build strong stakeholder relationships, monitor submission performance, and drive quality improvements. This is a high-impact opportunity to contribute to the efficient advancement of clinical development programs and, ultimately, therapies that benefit patients.

Accountabilities

• Lead end-to-end Clinical Trial Application project management across multiple studies, countries, and regulatory environments.
• Plan, coordinate, track, and deliver clinical trial submissions in accordance with regulatory requirements and agreed timelines.
• Apply strong knowledge of EU Clinical Trials Regulation (EU CTR) and relevant Rest of World CTA requirements to support compliant submissions.
• Manage submission documentation, dependencies, risks, issues, and complexities across global regulatory projects.
• Coordinate effectively with cross-functional and geographically distributed teams to ensure submission deliverables are complete, accurate, and delivered on schedule.
• Build and maintain productive relationships with internal and external stakeholders, facilitating alignment and resolving conflicts when required.
• Monitor key performance indicators related to submission timelines, deliverable quality, and project execution.
• Identify potential risks proactively and lead or support quality investigations and corrective actions where necessary.
• Maintain clear project tracking and communication throughout the submission lifecycle.
• Contribute to continuous improvements in regulatory submission processes, tools, and ways of working.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, or a related discipline.
• 5+ years of relevant industry experience within pharmaceutical, clinical research, CRO, or a comparable life sciences environment.
• Demonstrated experience managing Clinical Trial Application submissions across EU CTR and Rest of World regions.
• Strong project management experience, ideally within global, matrixed, or multinational organizations.
• Solid understanding of clinical trial processes and regulatory requirements.
• Practical knowledge of regulatory submission planning, execution, documentation, and compliance.
• Strong risk and issue management skills, with the ability to anticipate challenges and implement effective solutions.
• Excellent stakeholder engagement and communication skills, with the ability to work effectively across functions and geographies.
• Strong analytical, organizational, problem-solving, and decision-making abilities.
• Adaptability and resilience when managing changing priorities, complex projects, and tight regulatory timelines.
• Collaborative mindset with the ability to work independently while contributing effectively within global teams.

Benefits

• Fully remote working opportunity from India.
• Opportunity to contribute to global clinical development programs within the life sciences industry.
• Exposure to EU CTR and international regulatory submission environments.
• Collaboration with multidisciplinary and geographically distributed teams.
• Opportunities to develop expertise in clinical trial submissions, regulatory affairs, and global project management.
• A purpose-driven environment focused on advancing healthcare and supporting the development of therapies that can benefit patients.
• An inclusive and collaborative culture that values empathy, teamwork, adaptability, and professional growth.