Combination Products, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
Director of Regulatory Affairs will manage US investigational new drug (IND) applications, ex-US clinical trial applications (CTA), new drug applications (NDA) and related correspondence from the US Food and Drug Administration (FDA) and other regulatory authorities. Represents Regulatory Affairs in interdepartmental teams and projects.
Essential Duties and Responsibilities:
Execute, independently or with very limited guidance and supervision, product development and regulatory strategies regarding submissions and/or compliance issues
Manages the preparation, submission and maintenance of US and ex-US Regulatory applications, including routine amendments, annual reports, IND safety reports, and correspondence to FDA in both paper and electronic format
Works with external vendors to plan, prepare, submit, and maintain CTAs in Europe, Asia, and other regions as needed.
Primary contact with regulatory agencies for regulatory compliance and global product registrations.
Manages FDA submissions, including Pre-IND or NDA meeting planning, follow ups, and inspections.
Represent Regulatory Affairs in cross-functional clinical development program teams
Review clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance’s and alignment with study objectives
Identify potential areas of regulatory compliance vulnerability and risk; develops/implements corrective action plans for issue resolution, and provide general guidance on avoiding related problems in the future.
Provide guidance on Quality and SOPs relevant to the regulatory function.
Coordinate corporate wide on-going regulatory training to Verrica office, field colleagues, medical congress booth staff, as well as speakers and vendors on regulatory issues pertaining to product promotions.
Regularly monitor the regulatory compliance trends in the industry, interpret new regulations, guidance documents and enforcement activities, and evaluate the impact on the industry and the company.
Lead development of commercial regulatory strategies, policies, cross-functional projects, and interdepartmental decision-making.
Manage interdepartmental regulatory matters and provide regulatory guidance to other departments.
Bachelor's degree or higher degree with 12 years biopharmaceutical industry experience, including 10 years in Regulatory Affairs; equivalent combination of advanced degree and less experience will be considered.
Experience with drug-device combination products is a plus.
Excellent regulatory, writing, technical and problem-solving skills.
An understanding of relevant regulations and quality assurance requirements and a demonstrated ability to contribute to regulatory activities and deliver against program timelines required.
Internal Number: Reg-001
About Verrica Pharmaceuticals
Verrica Pharmaceuticals Inc. is an innovative clinical-stage medical dermatology company. We are committed to identifying, developing, and commercializing novel pharmaceutical products for the treatment of skin diseases and conditions with significant unmet needs. We seek to understand the patient journey and the healthcare provider landscape when developing our clinical programs, with the goal of delivering treatment solutions for millions of underserved patients.
Headquartered in West Chester, Pennsylvania, Verrica was founded in 2013. We are led by a seasoned management team with extensive pharmaceutical industry experience ranging from drug development through commercialization and collectively launched more than 50 products.