Job Description

We are seeking an experienced Associate Director of Regulatory Affairs who is passionate about regulatory strategy and is an outside of the box thinker. The ideal candidate will have early-stage R&D and inhalation or combination product experience. As the AD of Reg Affairs, you will have responsibility for all regulatory applications (INDs, BLAs, NDAs, 510k, EU MAA and Tech Dossier) and serve as health authority for those applications. You will develop and implement strategies for timely submission and approval of pre-clinical, clinical, CMC, labeling amendments and supplements, including file and document organization and management. Your role on the team is to be responsible for providing guidance on regulatory requirements, focusing on the regulatory operations aspects of regulatory affairs and other areas of expertise such as CMC, clinical, labeling, ad promo, and med device. Associate Director of Regulatory Affairs overview :

• Project manage, when necessary, the development of regulatory submissions
• Assists with coordinating, reviewing and preparing reports for submissions
• Provide guidance on regulatory concerns, issues and requirements
• Oversee the preparation of responses to deficiency comments/letters from health
• Author internal regulatory documents, such as Regulatory Assessments and Strategy
• Identify required activities, assign priorities and develop timelines
• Establish core tracking plan for documentation required in all regulatory submissions
• Prioritize and sequence regulatory support for multiple clients and regulatory matters
• Perform Regulatory Operations activities in the assembly and submission of applications to health authorities
• Maintain a controlled documentation system, record retention, and information services functions including electronic records retention processes.
• Understand and stay abreast of regulatory guidelines and regulations within the U.S. and key international environments and relevant therapeutic areas
• Responsible for observing all Company, Health, Safety and Environmental guidelines

Associate Director of Regulatory Affairs qualifications :

• 8+ years of experience working in the pharmaceutical and/or medical device industry with inhalation products being ideal
• BS/BA, MS, or PhD/MD in the life sciences
• Knowledge of US and EU regulatory guidelines, regulations, and requirements are essential
• Experience with early-stage R&D products and programs
• Combination product knowledge is a plus
• Proven experience with interpretation of deficiency comments and guide the formulation of responses
• Experience with reviewing internal change controls and assess impact to regulatory filings
• Demonstrated ability to analyze and interpret complex problems data, through effective decision making and planning
• Informed and connected with FDA, ICH, EU guidelines and regulations pertaining to Regulatory Affairs
• Strong meeting facilitation and decision-making skills

Industry: Regulatory Affairs, Pharmaceuticals, Medical Device, R&D, Inhalation, Combination Products Job Code: j-1453