Associate Director – Regulatory Affairs

This is a fully remote position, open to applicants in Alabama, +8 more states.

📋 Description

• Develop and execute comprehensive regulatory strategies in alignment with current FDA guidelines and industry trends.

• Provide regulatory oversight throughout the preclinical, clinical, and manufacturing phases of product development.

• Identify and proactively address regulatory risks.

• Manage the preparation, submission, and oversight of INDs, NDAs, ANDAs, and amendments to the FDA.

• Organize and implement submission schedules to ensure timely filings and approvals.

• Collaborate with R&D, Clinical Affairs, Quality, Manufacturing, internal teams, and external stakeholders.

• Act as the primary FDA liaison for designated development programs.

• Coordinate and facilitate Pre-IND, End-of-Phase, Pre-NDA, PDEV, and Control Correspondence meetings with the FDA.

• Address FDA inquiries and requests promptly.

• Ensure regulatory compliance in launch preparations, advertising, promotional materials, and post-marketing surveillance.

• Assist with REMS coordination and adherence to post-approval regulatory obligations.

• Stay updated on FDA regulations, guidelines, and evolving industry trends.

• Mentor, train, and guide junior regulatory personnel.

• Represent Regulatory Affairs in both internal and external meetings.

• Travel 15%, primarily within the domestic U.S., with 1–2 international trips annually.

⛳️ Requirements

• An advanced degree in life sciences, pharmacy, or a related discipline.

• 7–10+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology sectors.

• Demonstrated success in leading and managing ANDA, IND, and NDA submissions and approvals with the FDA.

• Experience in regulatory strategy formulation for generic drugs and combination products.

• In-depth knowledge of FDA regulations and guidelines, including regulatory requirements for preclinical, clinical, and CMC submissions.

• Outstanding project management abilities with the capacity to handle multiple priorities and deadlines.

• Strong analytical and problem-solving capabilities.

• Excellent communication and interpersonal skills.

• Preferred: At least 7 years of experience in Regulatory Affairs at successful generic pharmaceutical companies in the U.S. focusing on ANDA submissions.

• Preferred: 2 years of experience leading and successfully managing ANDA, IND, NDA submissions and approvals with the FDA.

• Willingness to travel 15%, primarily domestically, with 1–2 international trips annually.

🏝️ Benefits

• Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.

• Affordable Access Done with CARE.