Senior Manager, Regulatory Affairs - Permanent - New Jersey
Looking for your next chapter within Regulatory Affairs? This position leading projects and working in a collaborative team is your next new start!
Proclinical is partnering with an innovative commercial-stage company advancing a pipeline of novel therapies. With multiple programs in development, they're looking to bring on a Senior Manager, Regulatory Affairs to lead critical projects and ensure seamless execution of global submission strategies.
Applicants must have legal authorization to work in the United States.
Primary Responsibilities:
This is a visible role supporting INDs, NDAs, and global applications, while shaping submission plans and providing cross-functional guidance. Ideal for someone who's managed regulatory projects hands-on, contributed to agency interactions, and enjoys working in dynamic, collaborative teams.
What You'll Bring:
- 5-8 years of Regulatory Affairs experience in biotech/pharma
- Proven success with INDs and global submissions; NDA/MAA exposure a plus
- Strong project management, communication, and cross-functional skills
- Ability to balance strategic input with hands-on execution
What You'll Do:
- Lead regulatory projects supporting clinical development and global filings
- Drive the authoring, review, and submission of key regulatory documents
- Represent Regulatory Affairs on cross-functional teams and guide timelines
- Support agency interactions, submission readiness, and compliance processes
Compensation:
- $130,000 to $145,000 per annum.
If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at n.walker@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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