1 Senior Manager Regulatory Affairs Job in Summit, NJ
Scientific Search is Hiring a Senior Manager Regulatory Affairs Near Summit, NJ
Position Summary: Join our team as a Senior Manager of Regulatory Affairs in Summit, NJ. You will oversee regulatory strategies and submissions, ensuring compliance with FDA and EMA guidelines. This pivotal role requires a blend of expertise in regulatory documentation, eCTD submissions, and operational oversight, ideal for a seasoned professional with a strong foundation in the pharmaceutical industry, particularly in biologics or oncology.
Why You Should Apply
- Leadership Opportunity: Drive regulatory strategies and manage critical submissions.
- Professional Development: Enhance your expertise in a role central to our regulatory success.
- Innovative Environment: Contribute to pioneering treatments in biologics and oncology.
- Competitive Compensation: Attractive salary and benefits package.
- Dynamic Team: Work alongside industry experts in a collaborative environment.
- Manage all aspects of regulatory submissions (IND, BLA, NDA) using eCTD.
- Ensure archival and retrieval of documents through Veeva Vault RIM.
- Maintain up-to-date project files and compliance with regulatory standards.
- Draft necessary documentation and cover letters for submissions.
- Review and update SOPs to reflect current regulatory requirements.
- Hold a Bachelor’s degree in the sciences with at least 5 years in US regulatory affairs.
- Experienced in eCTD format and FDA/EMA regulatory frameworks.
- Proficient with Veeva Vault and potentially DocuBridge.
- Excellent communication skills and detail-oriented approach.
#IND1
Job Summary
Full Time
Ambulatory Healthcare Services
$152k-202k (estimate)
08/26/2024
10/17/2024
scientificsearch.com
CHERRY HILL, NJ
25 - 50
1983
ALLEN C ZECHOWY MDPHD
<$5M
Ambulatory Healthcare Services
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About Scientific Search
Scientific Search is a leader in the placement of technology professionals. Our technology areas of specialization include engineering, pharmaceutical & biotech, market research and information technology. Our client base is predominately centered in the corridor stretching from Philadelphia to New Jersey and the New York metropolitan area. We do, however, conduct a significant portion of our business outside of our primary market territory, both regionally and nationally. We are a full service employment agency offering multiple staffing options. From contract placements to direct placements ...and everything in between, Scientific Search works with employers and technology professionals to find the perfect solution. Scientific Search was founded in 1983 and has been providing recruiting and staffing excellence for twenty years. We have survived and excelled through a combination of hard work, knowledge and integrity. We are the firm that leading employers depend on to solve their staffing needs, and technology professionals trust to find challenging, rewarding positions. To learn more about Scientific Search, please visit our website at www.scientificsearch.com or call 856-761-0900.
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The job skills required for Senior Manager Regulatory Affairs include Regulatory Affairs, Leadership, SOP, Communication Skills, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Manager Regulatory Affairs. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Manager Regulatory Affairs. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Senior Manager Regulatory Affairs positions, which can be used as a reference in future career path planning. As a Senior Manager Regulatory Affairs, it can be promoted into senior positions as a Regulatory Affairs Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Senior Manager Regulatory Affairs. You can explore the career advancement for a Senior Manager Regulatory Affairs below and select your interested title to get hiring information.
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