Director, US Regulatory Affairs
Altimmune, Inc. · Morristown, NJ · 2 wk ago
ManagementFull-time
About the role
The successful candidate will lead the regulatory strategy for US operations, ensuring compliance with FDA regulations and international guidelines.
Responsibilities
- Develop and implement regulatory strategies for US operations
- Oversee all aspects of regulatory submissions and interactions with regulatory authorities
- Collaborate with cross-functional teams to ensure product development aligns with regulatory requirements
- Manage relationships with regulatory agencies and consultants
- Stay updated on regulatory changes and industry trends
Requirements
- Bachelor’s degree in a relevant field
- Minimum 10 years of experience in regulatory affairs or related field
- Proven track record in leading regulatory initiatives
- Experience with FDA and international regulatory bodies
- Strong leadership and interpersonal skills
Qualifications
- Excellent written and verbal communication skills
- Ability to manage multiple projects simultaneously
- Proficiency in regulatory compliance processes
- Knowledge of pharmaceutical or biotech industry
Skills
- Strong understanding of FDA regulations and guidelines
- Experience with regulatory filings and submissions
- Excellent organizational and project management skills
- Ability to work independently and as part of a team
Benefits
- Competitive salary package
- Flexible working hours
- Professional development opportunities
- Health insurance benefits
Pay
- $120,000 - $150,000 annually
Schedule
- Full-time
Contact Information
To apply, please fill out the application form below.
For more information about the company and the role, visit altimmune.com.
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