Senior Regulatory Affairs Associate

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

📋 Description

• Oversee the comprehensive management of Clinical Trial Application projects across various studies and countries.

• Strategically plan, monitor, and execute submissions in accordance with timelines and regulatory standards.

• Address risks, dependencies, and complexities within global regulatory landscapes.

• Utilize expertise in EU CTR and ROW CTA regulations.

• Administer essential clinical and regulatory documentation.

• Work collaboratively with cross-functional teams on a global scale.

• Establish and nurture stakeholder relationships while effectively resolving conflicts.

• Track key performance indicators related to timelines and the quality of deliverables.

• Recognize risks and spearhead quality investigations when necessary.

⛳️ Requirements

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

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

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

• Strong project management skills in a global or matrix setting.

• Knowledge of clinical trials and regulatory procedures.

• Excellent communication and problem-solving abilities.

• A strong sense of adaptability, resilience, and teamwork.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and training.

• Comprehensive health and wellness programs.

• Flexible working arrangements and a supportive work environment.