Associate Director/Director – Regulatory Affairs
Padagis LLC
full-time
Posted on:
Location Type: Remote
Location: Alabama • Colorado • United States
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Job Level
About the role
- Oversee regulatory strategies, submissions, and writing for pharmaceutical products targeted for the U.S. market
- Work cross-functionally with internal teams and external stakeholders to ensure regulatory compliance
- Provide consultation on regulatory aspects during the development phase
- Ensure all activities are planned and executed for a successful submission
- Guide products through the development pipeline and secure FDA approval
Requirements
- Advanced degree in life sciences, pharmacy, or a related field
- 7–10+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry
- Proven track record of leading and successfully managing ANDA, IND, NDA, submissions and approvals with the FDA
- Experience in regulatory strategy planning for generic drugs and combination products
- Strong knowledge of FDA regulations and guidelines, including regulatory requirements for preclinical, clinical, and CMC submissions
- Exceptional project management skills with the ability to manage multiple priorities and deadlines
- Strong analytical and problem-solving skills with a proactive and solutions-oriented mindset
- Excellent communication and interpersonal skills for effective collaboration with internal teams, external partners, and regulatory agencies.
Benefits
- Remote work options
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategyANDA submissionsIND submissionsNDA submissionsFDA approvalregulatory compliancepreclinical submissionsclinical submissionsCMC submissionsregulatory requirements
Soft Skills
project managementanalytical skillsproblem-solving skillscommunication skillsinterpersonal skillscollaborationproactive mindsetsolutions-oriented mindset
Certifications
advanced degree in life sciencesadvanced degree in pharmacyadvanced degree in related field