Associate Director/Director – Regulatory Affairs

Remote role Full-time Open position

Job Description

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.

Remote work options
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