Regulatory Affairs Consultant / Senior Consultant - Clinical Regulatory Affairs

About the role

At Parexel, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

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, including large, multinational studies spanning multiple regions and regulatory jurisdictions.
• Serve as the regulatory lead within cross-functional teams, partnering with Clinical Development, Medical Writing, Biostatistics, Quality, CROs, vendors, and external stakeholders to drive program success.
• Manage and support regulatory submissions and maintenance activities, including IND applications, annual reports, safety submissions, CTA-related activities, protocol amendments, informed consent updates, and end-of-trial deliverables.
• Provide strategic support for health authority interactions, including preparation of meeting requests, briefing packages, regulatory intelligence assessments, and responses to agency questions.
• Contribute to key development and registration initiatives by supporting NDA/MAA/BLA readiness activities, reviewing clinical documentation packages, and ensuring alignment of regulatory strategy across programs.
• Author and review regulatory documentation as needed, while partnering with dedicated authoring teams on major submission content.
• Conduct regulatory impact assessments, identify risks, and develop proactive mitigation strategies to keep programs on track.
• Facilitate issue resolution across multidisciplinary teams and build alignment among stakeholders to address challenges before they become barriers to success.
• Ensure compliance with FDA, EMA, HC regulations, ICH guidelines, and applicable global regulatory requirements.

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, ICH guidelines, and global regulatory pathways.
• Experience supporting IND/CTAs applications, annual reports, safety submissions, and related clinical regulatory activities.
• Experience preparing or supporting health authority meetings and regulatory communications.
• Understanding of global clinical trial applications and regulatory requirements across multiple regions.
• Familiarity with electronic submission systems and regulatory publishing processes.
• Ability to independently manage complex regulatory projects while influencing cross-functional teams and stakeholders.
• Strong written, verbal, analytical, and problem-solving skills.
• Bachelor's degree in a scientific or technical discipline required; advanced degree strongly preferred.
• Experience with FDA, EMA and other major market regulations and meeting packages required.
• Experience working with international health authorities and global regulatory submissions strongly preferred.

Preferred Qualifications

• Experience supporting large global clinical trials and coordinating regulatory activities across multiple countries.
• Background in oncology, immunology, immuno-oncology, or other complex therapeutic areas.
• Project Management Professional (PMP) certification or comparable project management experience.
• Demonstrated success managing multiple priorities, timelines, budgets, and stakeholder groups in a fast-paced development environment.