Senior Regulatory Affairs Associate – Clinical Trial Application

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee comprehensive CTA project management across various studies and countries.

• Organize, monitor, and fulfill submissions in accordance with timelines and regulatory standards.

• Navigate risks, dependencies, and complexities within global regulatory frameworks.

• Leverage knowledge of EU CTR and ROW CTA guidelines.

• Manage essential clinical and regulatory documentation.

• Collaborate effectively with cross-functional global teams.

• Establish and nurture stakeholder relationships while resolving conflicts.

• Track KPIs related to timelines and the quality of deliverables.

• Identify potential risks and lead quality investigations as necessary.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline.

• At least 5+ years of professional experience in the pharmaceutical industry, CRO, or a similar field.

• Proven experience with Clinical Trial Application submissions (EU CTR & ROW).

• Strong project management skills in a global/matrix environment.

• Knowledge of clinical trials and regulatory procedures.

🏝️ Benefits

• Flexible remote working options.

• Opportunities for career advancement and professional growth.