Full-Time
Regulatory Affairs Manager
Integrated Resources
501-1,000 employees
No salary listed
Lexington, MA, USA
In Person
 Legal & Compliance (2) |
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- Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.
- Prior management experience, with a demonstrated capability to lead and motivate staff is essential.
- Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products.
- Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development.
- Develop regulatory submission strategies in agreement with defined product development objectives.
- Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applications projects.
- Prepare and submit IND and NDA applications, as well as various amendments and supplements.
- Demonstrated strategic development capabilities related to new drug development and commercial support activities are critical.
Company Size
501-1,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Edison, New Jersey
Founded
1996
Simplify's Take
What believers are saying
- Certification boosts appeal to quality-focused healthcare organizations.
- Reskilling programs cut time-to-hire amid workforce shortages.
- Positions IRI among 15,000 Joint Commission-accredited elite firms.
What critics are saying
- Certification lapses in 12-18 months from failed onsite review.
- Patient complaints trigger decertification and client losses in 6-12 months.
- AMN Healthcare captures IRI's mid-sized clients in 12-24 months.
What makes Integrated Resources unique
- Joint Commission Gold Seal certifies IRI's staffing compliance since 2009.
- AI tool Nova hybridizes with reskilling to close healthcare skills gaps.
- Focuses on diversity hiring and performance monitoring for elite placements.
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Benefits
Wellness Program
Mental Health Support
Flexible Work Hours
Phone/Internet Stipend
Home Office Stipend
Conference Attendance Budget
Company News
Edison, New Jersey - Integrated Resources Inc. has earned The Joint Commission's Gold Seal of Approval(R) for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.
Integrated Resources Inc. has earned The Joint Commission’s Gold Seal of Approval ® for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.