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Regulatory Affairs Specialist--Home based New York
This job is now closed
Job Description
- Req#: R76571
Employer Industry: Medical Devices and Drug Products
Why Consider this Job Opportunity:
- Salary up to $114,700.00
- Opportunity for career advancement and growth within the organization
- Comprehensive health plan benefits
- Remote working options available
- Supportive and inclusive work environment
What to Expect (Job Responsibilities):
- Support regulatory submissions such as 510K, INDs, NDAs, ANDAs, and DMFs
- Review and develop product labeling in compliance with FDA regulations
- Contribute to the development of regulatory strategies for clients' products
- Develop and maintain strong relationships with clients, providing expert guidance
- Demonstrate understanding of financial concepts to enhance profitability
What is Required (Qualifications):
- Bachelor's degree in life sciences, pharmacy, or related field
- Experience in regulatory affairs with a focus on labeling and regulatory submissions
- Strong knowledge of FDA regulations, guidelines, and submission processes
- Excellent project management skills
- Proficient in Microsoft Office Suite and regulatory submission software
How to Stand Out (Preferred Qualifications):
- Advanced degree in a related field
- Experience in developing Structured Product Labeling (SPL) documents
- Familiarity with financial concepts in regulatory consulting services
#RegulatoryAffairs #FDARegulations #ClientRelationships #RemoteWorkOpportunity #CareerGrowth
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