When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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, you'll 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 client's 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 You'll 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.
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.
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 you're passionate about regulatory strategy, thrive in collaborative environments, and want to make a meaningful impact on the development of innovative therapies, we'd love to hear from you.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Skills Required
- At least 5 years of regulatory affairs experience including clinical regulatory affairs
- A minimum of a bachelor's degree in a scientific or technical discipline
- Knowledge of FDA Regulations and experience with FDA meeting requests
- Project management / leadership experience
- Excellent interpersonal and intercultural communication skills
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
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What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
