Regulatory Affairs Director jobs in Kentucky

 Essential Functions:

• Primary responsibilities will include extensive writing of client deliverables to support agreed regulatory and clinical strategy.
• North American and EU experience is highly preferred.
• Lead and participate in drug development projects, including strategic development plans, Pre-Investigational New Drug (Pre-IND), IND, New Drug Application (NDA) and Biologic License Application (BLA), Investigational Device Exemption (IDE), and other regulatory documents
• Ideally experienced in device projects to support 510K, PMAs, LVD, IVD is a plus
• Provide drug / device regulatory guidance to project teams and clients; facilitate and lead interactions with regulatory authorities (eg, Food and Drug Administration [FDA], European Medicines Agency [EMA], and Health Canada)
• Conduct scientific research and assimilate data into written deliverable products for clients, including abstracts, clinical study protocols, clinical study reports (CSRs), written summaries, training materials, briefing documents and other medical writing documents intended for submission to regulatory authorities
• CMC and/or nonclinical demonstrable experience is required, along with ability to support clinical/medical writing projects
• Provide direction to team members and oversee regulatory and scientific affairs projects
• Lead and participate in advisory boards, training programs, and review scientific writing projects, including manuscripts, monographs, briefing documents, and market analysis
• Interact professionally with clients, thought leaders, and external consultants to understand their objectives and meet their needs
• Participate in business development (BD) capabilities presentations, client visits, and programs
• Collaborate with Medical Affairs, Biostatistics, Data Management, Clinical Project Management, and other disciplines as needed to meet internal and external client objectives
• Provide project status reports to senior/executive management and project management leads
• Present information at internal and external meetings
• Maintain ongoing knowledge of updated US and Global regulatory requirements, guidance documents, and best practices
• Support senior and executive management in the enhancement of departmental performance and development of best practices
• Develop and conduct internal/external training and continuing education activities
• Develop and maintain knowledge and expertise across multiple therapeutic areas through clinical ongoing awareness of industry practices, and participate in professional development activities
• Provide input into and/or lead the development of or improvement of internal processes and operations
• Mentor and provide guidance to scientists, project managers, and other associates within and outside the Department

Competencies:

• Demonstrated scientific research skills with attention to detail and ability to integrate scientific medical information with superior written communication skills
• Experience with development of complex technical documents including regulatory planning strategies, pediatric research plans, Pre-IND/Pre-Submission meeting requests, IND, NDA, BLA, and others as applicable
• Able to work effectively in a team setting
• Capable of effectively handling multiple projects simultaneously with ability to prioritize tasks to meet client or departmental needs
• Extensive knowledge of relevant International Council for Harmonisation (ICH) guidelines and applicable regulatory requirements and standards for global regulatory agencies
• Understanding of the processes and guidance related to interactions with regulatory authorities
• Strong scientific or drug development background and demonstrated research skills
• Demonstrated ability to lead teams responsible for assimilation of complex medical/health-related information
• Excellent verbal and written communication skills
• Ability to work in an autonomous manner with minimal direction and with self-motivation
• Demonstrated effectiveness working with clients, external stakeholders, and third-party vendors
• Strong working knowledge of the drug and device development process and associated regulatory requirements
• Advanced technical skills in Microsoft Office including Word, PowerPoint, and excel and ability to learn and adapt to new systems and technologies to perform job functions
• Understanding of basic business-related financial and business development concepts

 Required Education/Experience:

• Masters of Science, Masters of Public Health, Master’s, or Doctoral degree in fields such as allied health, nursing, pharmacy or natural sciences or Bachelor’s degree with appropriate level of experience in Regulatory and Scientific Affairs
• At least 10 years of direct experience working in the pharmaceutical industry (eg, contract research organization or pharmaceutical company) or related area with a focus in drug development, regulatory affairs, and/or medical writing; or at least 7 years of experience with an advanced degree in a related area (MD/DO/MBBS, PharmD, DrPH, PhD, MS, Nurse Practitioner) with experience in medical writing
• Demonstrated history of direct interaction with regulatory agencies (eg, FDA, EMA, Health Canada)
• Extensive experience in preparing technically complex documents intended for submission to regulatory authorities (eg, briefing documents, CSRs)
• Experience leading project teams and working effectively across multi-functional teams
• Industry and/or clinical experience with orphan and rare disease designations, hematology/oncology, immunology, and other complex medical disease states preferred