Regulatory Affairs Consultant / Senior Consultant - Clinical Regulatory Affairs

Location: Any Region, REMOTE, United States of America, Alabama, United States, Alaska, United States, Arizona, United States, Arkansas, United States, California, United States, Colorado, United States, Connecticut, United States, Delaware, United States, Florida, United States, Georgia, United States, Hawaii, United States, Idaho, United States, Illinois, United States, Indiana, United States, Iowa, United States, Kansas, United States, Kentucky, United States, Louisiana, United States, Maine, United States, Maryland, United States, Massachusetts, United States, Michigan, United States, Minnesota, United States, Mississippi, United States, Missouri, United States, Montana, United States, Nebraska, United States, Nevada, United States, New Hampshire, United States, New Jersey, United States, New Mexico, United States, New York, United States, North Carolina, United States, North Dakota, United States, Ohio, United States, Oklahoma, United States, Oregon, United States, Pennsylvania, United States, Rhode Island, United States, South Carolina, United States, South Dakota, United States, Tennessee, United States, Texas, United States, Utah, United States, Vermont, United States, Virginia, United States, Washington, United States, West Virginia, United States, Wisconsin, United States, Wyoming, United States, Remote

Employment Type: Remote

At Parexel, we are driven by a single purpose: to partner with our clients and help patients gain access to life-changing therapies faster.

We are currently seeking a Regulatory Affairs Consultant/ Senior Consultant to join a dedicated client partnership. In this role, youll play a critical part in advancing innovative therapies by guiding complex global clinical development programs through the regulatory landscape with strategy, insight, and collaboration.

As a Regulatory Affairs Consultant, you will serve as a trusted regulatory leader supporting a major pharmaceutical clients clinical portfolio. This highly visible role combines regulatory strategy, global project leadership, health authority engagement, and cross-functional collaboration across programs ranging from early clinical development through registration planning and lifecycle management.

This position focuses on health authority interactions, submission planning, compliance oversight, and some regulatory strategy input—not site-level study coordination or patient-facing activities.

What Youll Do

• 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.

Required Qualifications

• 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.

• Bachelors 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.

Why This Role

• Be a strategic regulatory partner for a major pharmaceutical client with direct visibility to senior regulatory and clinical leadership.

• Influence development programs from early clinical stages through registration planning and lifecycle management.

• Lead global regulatory activities for innovative studies, including complex multinational trials.

• Partner with cross-functional experts and contribute to high-impact health authority interactions and submission strategies.

• Join a trusted, long-term client partnership where your expertise will shape program decisions and drive meaningful outcomes for patients around the world.

If youre passionate about regulatory strategy, thrive in collaborative environments, and want to make a meaningful impact on the development of innovative therapies, wed love to hear from you.

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