As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Level: Mid
- Travel: Yes
- Glassdoor Reviews and Company Rating
Success Profile
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Management
Strong management with depth of experience working for global health authorities.
Responsibilities
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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