Associate Director – Regulatory Affairs

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🏈 Alabama, Colorado, +7 more states – Remote

🏈 Alabama – Remote ⛰️ Colorado – Remote 🐊 Florida – Remote 🌽 Illinois – Remote 🍂 Massachusetts – Remote 🚗 Michigan – Remote ❄️ Minnesota – Remote 🎸 Tennessee – Remote 🧀 Wisconsin – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 12%

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Padagis LLC

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

Padagis LLC is a pharmaceutical manufacturer focused on expanding access to high-quality, affordable topical and other non-oral medications. The company develops and produces a broad portfolio of prescription and over-the-counter extended topical products—including creams, ointments, gels, foams, sprays, patches, nasal treatments, and suppositories—and specializes in Paragraph IV generic products that navigate branded patent complexities. Padagis also pursues research and development, strategic partnerships, product acquisitions, and contract manufacturing to support healthcare providers, distributors, and patients.

📋 Description

• Develop and implement comprehensive regulatory strategies according to current FDA guidances and trends • Provide regulatory leadership during preclinical, clinical, and manufacturing stages of product development • Assess and proactively mitigate regulatory risks • Oversee preparation, submission, and management of INDs, NDAs, ANDAs, and amendments to the FDA • Plan and execute submission timelines for timely filings and approvals • Collaborate with R&D, Clinical Affairs, Quality, Manufacturing, internal teams, and external stakeholders • Serve as primary FDA contact for assigned development programs • Coordinate and facilitate Pre-IND, End-of-Phase, Pre-NDA, PDEV, and Control Correspondence meetings with the FDA • Respond to FDA queries and requests • Ensure regulatory compliance in launch preparation, advertising, promotional materials, and post-marketing surveillance • Support REMS coordination and compliance with post-approval regulatory commitments • Stay current with FDA regulations, guidances, and industry trends • Provide mentorship, training, and guidance to junior regulatory staff • Represent Regulatory Affairs in internal and external meetings • Travel 15%, mostly domestic, with 1–2 international trips yearly

🎯 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 • Excellent communication and interpersonal skills • At least 7 years of experience working in Regulatory Affairs at successful generic pharmaceutical companies in the US on ANDA submissions preferred • 2 years leading and successfully managing ANDA, IND, NDA submissions and approvals with the FDA • Willingness to travel 15%, mostly domestically, with 1–2 international trips yearly

🏖️ Benefits

• Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities • Affordable Access Done with CARE