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Regulatory Affairs Manager Job
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| Employer Name: Rising Pharma Holdings Inc. |
SpiderID: 13644144 |
| Location: East Brunswick, New Jersey |
Date Posted: 1/10/2024 |
| Wage: |
Category: Medical/Health |
| Job Code: |
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Job Description:
Regulatory Affairs Manager is needed to perform the following duties :
• Manage preparation for submissions: Original ANDA’s, Prior Approval Supplements, CBE-30s, CBE-0s, Annual Reports, etc.
• Responsible for assembly of ANDA submissions working directly with CMO’s and development partners.
• Track Regulatory activities via project management tools such as excel, MS project, etc
• Organize and update Regulatory files in Novo space and internal drives
• Experience with Adobe Illustrator® or equivalent is preferred.
• Responsible for labeling generation including inserts, container and carton labels, patient brochures, etc., and Labeling submissions to FDA.
• Responsible for preparation of post marketing reporting such as 15-Day MedWatch’s, Periodic Safety Reports, compiling relevant information provided by partners and CMO’
• Responsible for compiling information required for drug listing.
• Communicate and provide information to partners upon request
• Provide presentation material for management updates.
• Partner owned ANDAs: * Communicate and provide information to partners upon reques
• Partner owned ANDAs: * Work closely with partners and CMO’s for labeling development and review.
Bachelor’s Degree is required in Regulatory Affairs or Drug Regulatory affairs or education + experience which is equivalent to a Bachelor’s Degree in Regulatory Affairs or Drug Regulatory affairs
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: Rising Pharma Holdings Inc. |
Company Type: |
| Company: Rising Pharma Holdings Inc. |
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| City: East Brunswick |
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| State: New Jersey |
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