Employer Industry: Pharmaceuticals

Why consider this job opportunity:
- Competitive salary up to $120,000
- Opportunity for career advancement and growth within the organization
- Fully remote work option available
- Comprehensive benefits package including health insurance and retirement plans
- Chance to work on diverse projects and interact with various departments
- Supportive and collaborative work environment

What to Expect (Job Responsibilities):
- Provide regulatory assessment and support
- Evaluate and assess regulatory impact of proposed product changes
- Contribute to strategic planning as a regulatory representative
- Prepare and submit regulatory filings and correspondence to FDA and Health Authorities
- Review and advise on product labeling, promotional, and advertising material

What is Required (Qualifications):
- Bachelor’s Degree required; Advanced Degree desirable
- 5-8 years of related experience or equivalent
- In-depth knowledge of New Drug Applications (NDAs), ANDAs, INDs, sNDAs/ANDS, CBEs, Annual Reports, and PSURs
- Strong understanding of US drug or biologics guidelines and regulations
- Excellent interpersonal, verbal, and written communication skills

How to Stand Out (Preferred Qualifications):
- Prior experience with eCTD submissions
- Demonstrated working knowledge of scientific principles and domestic regulatory requirements
- Ability to work independently with minimal direction
- Prior experience in preparation of regulatory affairs documents

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