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.
About Parexel
Parexel is a leading global clinical development partner delivering insights driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.
About the Role
We are seeking a Regulatory & Submissions Lead to join our team in France in a hybrid capacity. This position is dedicated to a large single sponsor and requires 2 days per week onsite in Paris. The Regulatory & Submissions Lead is accountable for performance and compliance across assigned clinical trial protocols within the country, ensuring adherence to ICH/GCP guidelines, local regulations, sponsor policies and procedures, quality standards, and adverse event reporting requirements.
As a key contributor to clinical study startup and execution, you will play an important role in helping bring innovative therapies to patients by driving regulatory and ethics submissions, maintaining compliance, and supporting critical study milestones. You will collaborate with cross functional teams and build expertise within a dynamic clinical research environment where your work directly supports the advancement of global clinical development programs.
You’ll join a fast paced, growth-oriented environment focused on making a meaningful impact through regulatory excellence, study startup execution, and clinical research compliance. With diverse teams and continuous learning opportunities, the Regulatory & Submissions Lead can expand their expertise across clinical research and regulatory operations.
Key Responsibilities
- Lead local Ethics Committee and Regulatory Authority submissions, including initial submissions and protocol amendment submissions
- Independently prepare and manage submissions to Ethics Committees and Regulatory Authorities
- Complete and maintain XML documentation as required for submissions
- Prepare informed consent forms using approved templates
- Ensure compliance with ICH/GCP, country regulations, sponsor policies and procedures, quality standards, and adverse event reporting requirements
- Apply in depth knowledge of the local regulatory environment, submission processes, and approval pathways to support study startup activities
- Manage investigational medicinal product related local supply activities, including coordination with vendors providing background medications and standard of care supplies
- Review and validate translated study documents to support regulatory and study requirements
- Support protocol performance and compliance activities across assigned studies within the country
- Collaborate with study teams and stakeholders to facilitate timely regulatory approvals and study progress
Candidate Profile
You’ll thrive in this role if you bring:
- Strong expertise in regulatory submissions, clinical trial startup activities, and regulatory compliance
- Experience independently preparing submissions for Ethics Committees and Regulatory Authorities
- The ability to collaborate across teams and communicate clearly with internal and external stakeholders
- A patient focused mindset and strong attention to detail
- Comfort working with submission documentation, XML completion processes, informed consent documentation, and translated study materials
Required Qualifications
- Bachelor’s degree or equivalent combination of education and relevant experience
- Extensive experience in local Ethics Committee and Regulatory Authority submissions, including initial submissions and protocol amendments
- Experience independently preparing submissions to both Ethics Committees and Regulatory Authorities
- Experience preparing informed consent forms using approved templates
- Skilled knowledge of the local regulatory environment, submission requirements, and approval processes and their impact on study startup
- Experience managing local investigational medicinal product supply activities
- Experience validating translated documents
- Knowledge of ICH/GCP, regulatory requirements, and clinical trial processes
- Strong communication, organization, and problem solving skills
Preferred Qualifications
- Experience with country and site budget development, negotiation, and completion of Clinical Trial Research Agreements
- Experience overseeing and tracking clinical research related payments and payment reconciliation activities through study closeout
If this job doesn’t sound like the next step in your career, but perhaps you know of someone who would be a perfect fit, send them the link to apply!
We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.
Skills Required
- Bachelor’s degree or equivalent combination of education and relevant experience
- Extensive experience with local Ethics Committee and Regulatory Authority submissions, including initial submissions and protocol amendments
- Experience independently preparing submissions to Ethics Committees and Regulatory Authorities
- Experience preparing informed consent forms using approved templates
- Skilled knowledge of the local regulatory environment, submission requirements, and approval processes
- Experience managing local investigational medicinal product supply activities
- Experience validating translated documents
- Knowledge of ICH/GCP, regulatory requirements, and clinical trial processes
- Strong communication, organization, and problem-solving skills
- Experience with country and site budget development, negotiation, and Clinical Trial Research Agreements
- Experience overseeing and tracking clinical research payments and reconciliation through study closeout
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.
Parexel Insights
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.
