Regulatory & Submissions Lead (Clinical Operations Manger) - Paris, France (Hybrid) - FSP

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 at least 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.