Director of Regulatory Affairs

Key Responsibilities

• Oversee all regulatory activities for U.S.-marketed products, including prescription drugs, medical devices, and dietary supplements.
• Draft, review, and submit CMC and labeling supplements, annual reports, and PADERs to the FDA using the electronic Common Technical Document (eCTD) format.
• Conduct regulatory assessments for change controls and file reportable updates in line with FDA guidelines and regulations.
• Provide regulatory guidance for promotional material reviews and ensure appropriate submissions to the FDA’s Office of Prescription Drug Promotion (OPDP).
• Maintain and organize all regulatory-related documents to ensure compliance.
• Act as the primary point of contact for FDA communications and submissions.
• Oversee the design and proofing of labeling artwork in coordination with designers and contract manufacturing organizations (CMOs).
• Manage the renewal of NDA registrations, device registrations, and updates to FDA listings.

Additional Responsibilities

• Business Development: Evaluate regulatory considerations for potential product acquisitions.
• Audits & Inspections: Support internal and external audits, including FDA and state-level inspections.

Core Competencies and Expertise

• Proven ability to multitask across technical, regulatory, and quality functions.
• Deep expertise in regulatory operations, including preparing CMC, labeling supplements, and promotional materials using eCTD standards.
• Strong experience with post-marketing reports for products approved under the 505(b) pathway.
• Thorough understanding of FDA regulations for NDA products, medical devices, and dietary supplements.
• Knowledge of compliance requirements (e.g., CARES Act, Sunshine Act) and state-level licensing.
• Demonstrated leadership skills, team collaboration, and adaptability in dynamic settings. Skilled in budget management and team supervision.

Qualifications and Skills

• Education & Experience: 7 years of direct regulatory experience in the industry, with at least 3 years in a leadership role.
• Language: Fluency in English; Spanish proficiency is a plus.
• Specific Expertise: Strong understanding of FDA regulations, NDA and post-approval submissions, cGMP, and CMC regulatory assessments. Proficient in preparing eCTD-format submissions.
• Travel: Up to 5%.
• Personal Skills: Strong management and interpersonal skills, results-oriented mindset, problem-solving ability, and team development expertise.