Regulatory Affairs Manager
About this role
Company Description
US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website www.ustechsolutions.com.
We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, sets the correct expectation and thus becomes an accelerator in the mutual growth of the individual and the organization as well.
Keeping the same intent in mind, we would like you to consider the job opening with US Tech Solutions that fits your expertise and skillset.
Job Description
- 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 (NDA) projects. Prepare and submit IND and NDA applications, as well as various amendments and supplements.
- 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.
- Demonstrated strategic development capabilities related to new drug development and commercial support activities are critical.
Qualifications
- 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.
- Prepare and submit IND and NDA applications, as well as various amendments and supplements.
Additional Information
Thanks and regards,
Sneha Shrivastava
862 579 4236
Frequently Asked Questions
Is the salary disclosed for the Regulatory Affairs Manager position at ustechsolutions2?
The salary for this Regulatory Affairs Manager role at ustechsolutions2 is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regulatory Affairs Manager position at ustechsolutions2 located?
This Regulatory Affairs Manager role at ustechsolutions2 is based in IL, Lake Forest, Lake Forest, IL, United States, us. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
How do I apply for the Regulatory Affairs Manager position at ustechsolutions2?
Click the "Apply Now" button on this page. You will be redirected to ustechsolutions2's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the Regulatory Affairs Manager job at ustechsolutions2 posted?
This Regulatory Affairs Manager position at ustechsolutions2 was posted on Oct 13, 2016. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affairs Manager
ustechsolutions2
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