Associate Director/Director – Regulatory Affairs

Padagis LLC

. Oversee regulatory strategies, submissions, and writing for pharmaceutical products targeted for the U.S.

Posted 4/2/2026full-timeRemote • Alabama, Colorado, Florida, Illinois, Massachusetts, Minnesota, Missouri, Tennessee, Wisconsin • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Remote work options
Professional development opportunities

ATS Keywords

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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