Regulatory Operations Submissions - various levels - US or Canada (Talent Pool)
United States of America, Remote Job ID R0000032233 Category Consulting Date Posted 03/24/2025Overview
As part of Parexel Consulting, 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.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
Attention Senior Submissions Specialists and Regulatory Operations Submissions Managers
Drive Regulatory Excellence in a Growing FSP Partnership
Due to our ongoing success, we expect to be growing our North American Regulatory Operations team!
As we prepare for future growth, we are actively seeking exceptional candidates to join our team, we are seeking talented professionals to join our team as:
Senior Submissions Specialists, Regulatory Operations
Regulatory Operations Submissions Managers
These positions will partner with a large, dedicated client in our Functional Service Provider (FSP) Program, offering an exciting opportunity to contribute to regulatory success while supporting our company's growth.
In these crucial roles, you will:
Manage the preparation and submission of regulatory documents to health authorities
Ensure compliance with global regulatory requirements and submission standards
Coordinate with cross-functional teams to gather and organize submission components
Oversee the use of electronic submission tools and platforms
Contribute to the development and improvement of submission processes
Provide expert guidance on regulatory operations best practices
The ideal candidates will bring:
Extensive experience in regulatory submissions and operations
In-depth knowledge of eCTD requirements and electronic submission processes
Strong project management and organizational skills
Excellent attention to detail and quality focus
Ability to work effectively in a client-embedded environment
Experience with leading submission management tools and systems
For Senior Submissions Specialists:
3+ years of experience in regulatory submissions
Proven track record of successful regulatory filings
For Regulatory Operations Submissions Managers:
5-7+ years of experience in regulatory submissions and operations
Demonstrated leadership in managing complex submission projects
Experience in mentoring and guiding junior team members
Ideally candidates will be located in EST. Consideration, however, will be given to experienced Regulatory Professionals within the US or Canada in other regions who have the ability to work EST hours.
These roles offer the opportunity to work with a dedicated client, providing consistent, high-quality regulatory support while developing deep expertise in their product portfolio and processes. You'll be part of a growing team, with potential for career advancement as our partnership expands.
If you're ready to leverage your regulatory submissions expertise in a dynamic, client-focused environment, we want to hear from you. Join us in shaping the future of regulatory affairs and making a lasting impact on global healthcare through effective strategy and execution.
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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 United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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