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

We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.