Regulatory Operations Submissions - various levels - US or Canada (Talent Pool)

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.