Regulatory Affairs Consultant/Senior Consultant - Clinical Regulatory Affairs

Responsibilities

• Execute global regulatory strategies that support clinical development and long-term registration objectives.
• Lead and coordinate regulatory activities across U.S., EU, and international clinical trials.
• Serve as the regulatory lead within cross-functional teams, partnering with Clinical Development, Medical Writing, and Biostatistics.
• Manage and support regulatory submissions and maintenance activities, including IND applications, CTA-related activities, and safety submissions.
• Provide strategic support for health authority interactions, including the preparation of briefing packages and responses to agency questions.
• Contribute to NDA/MAA/BLA readiness activities and review clinical documentation packages.
• Conduct regulatory impact assessments and develop proactive mitigation strategies to manage program risks.
• Ensure compliance with FDA, EMA, HC regulations, and ICH guidelines.

Requirements

• Minimum 5+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or CRO industry.
• Demonstrated expertise in regulatory strategy, health authority engagement, and regulatory submissions.
• Strong knowledge of clinical development regulations, FDA & EMA requirements, and ICH guidelines.
• Experience supporting IND/CTAs applications, annual reports, and safety submissions.
• Experience preparing or supporting health authority meetings and regulatory communications.
• Bachelor's degree in a scientific or technical discipline is required.
• Strong written, verbal, analytical, and problem-solving skills.

Preferred Qualifications

• Experience supporting large global clinical trials and coordinating activities across multiple countries.
• Background in oncology, immunology, or immuno-oncology.
• Project Management Professional (PMP) certification or comparable experience.
• Experience working with international health authorities and global regulatory submissions.

About the Company

Parexel is a global leader in clinical research, driven by a purpose to help patients gain access to life-changing therapies faster. We provide expert regulatory, clinical, and functional services to biopharmaceutical and medical device companies worldwide.