This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Associate based in India.
This role offers the opportunity to support global clinical development programs by managing regulatory submissions and ensuring compliance across multiple regions.
You will contribute to bringing innovative therapies closer to patients by coordinating critical regulatory activities throughout the clinical trial lifecycle.
The position combines regulatory expertise, project management, and cross-functional collaboration within a global healthcare environment.
You will work closely with international teams to deliver high-quality submissions while managing timelines, risks, and regulatory requirements.
This is an ideal opportunity for a detail-oriented professional passionate about clinical research, compliance, and improving healthcare outcomes.
The role provides exposure to complex global regulatory processes and opportunities to grow within a collaborative life sciences environment.
Accountabilities:
As a Regulatory Affairs Associate, you will support the planning, coordination, and execution of clinical trial submissions while ensuring regulatory compliance and timely delivery. You will collaborate with global stakeholders, manage documentation, identify risks, and contribute to successful regulatory strategies across different regions.
- Support end-to-end planning and coordination of Clinical Trial Applications (CTA) across global regions.
- Assist in preparing, tracking, and delivering regulatory submissions according to timelines and applicable requirements.
- Coordinate regulatory documentation and ensure submission packages meet quality and compliance standards.
- Apply knowledge of clinical trial regulations, including EU Clinical Trial Regulation (EU CTR) and Rest of World (ROW) requirements.
- Collaborate with cross-functional teams including clinical, regulatory, and operational stakeholders.
- Maintain effective communication with internal and external stakeholders to support submission activities.
- Monitor project timelines, milestones, and key performance indicators related to submission quality and delivery.
- Identify potential risks, support issue resolution, and contribute to quality improvement initiatives.
- Maintain accurate regulatory records and ensure documentation readiness throughout project activities.
Requirements:
The ideal candidate has experience in regulatory affairs, clinical research, or related life sciences environments, with strong organizational skills and the ability to manage multiple priorities in a global setting.
- Bachelor’s degree in Life Sciences, Pharmacy, Healthcare, or a related discipline.
- Minimum of 3 years of experience in pharmaceutical, clinical research organization (CRO), or similar environments.
- Experience supporting or managing Clinical Trial Application submissions.
- Knowledge of EU CTR and global regulatory submission processes.
- Understanding of clinical trial operations and regulatory documentation requirements.
- Experience working in global, cross-functional, or matrixed teams.
- Strong project coordination and execution skills.
- Ability to manage risks, priorities, and timelines effectively.
- Excellent communication, stakeholder management, and problem-solving skills.
- Strong attention to detail, adaptability, resilience, and ability to work collaboratively.
Benefits:
- Remote work opportunity based in India.
- Opportunity to contribute to global clinical research programs and healthcare innovation.
- Exposure to international regulatory processes and cross-functional collaboration.
- Professional development opportunities within the life sciences industry.
- Work in a purpose-driven environment focused on improving patient outcomes.
- Opportunity to build expertise in global clinical trial submissions and regulatory operations.
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