Director, Regulatory Affairs, Home-Based - IQVIA Biotech
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To provide regulatory and quality support to select clinical research projects involving investigational or marketed products. To provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and organizations; to support regulatory agency interactions, communications, and submissions; and to review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.
To support submission of applications to competent authorities, identification of the central Institutional Review Board (IRB), Ethics Committee (EC), and essential regulatory documents required for multiple global projects, development of Regulatory Document Management Plan, review of initial regulatory documents for site activation, and maintenance of internal CTMS for tracking study site status site initiation through study maintenance. Work directly with Global Head of Regulatory Affairs, Director of Clinical Monitoring, EVP, Clinical Operations, Project Managers and Clinical Trial Managers in execution of multiple regulatory affairs projects.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Assist Global Head, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance issued by the applicable regulatory agency(ies).
- Manage/oversee assembly and submission of applications to competent authorities.
- Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
- Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
- Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects.
- Keep abreast of, interpret and communicate applicable regulatory agency regulations and statutes with internal departments and ensures IQVIA Biotech compliance.
- Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated IQVIA Biotech activities, as appropriate.
- Participates in business development activities to grow IQVIA Biotech business. Participates in new business development activities including, but not limited to, client meetings and proposal preparation/presentation.
- Directs the performance of the regulatory affairs staff. Develops project timelines, develops strategic goals with staff, and provides guidance as needed for completion of tasks. Assesses performance and recommends salary adjustments.
- Perform other related duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES:
- Extensive knowledge of clinical research and product development life cycles for investigational and marketed health care products.
- Extensive working knowledge of activities related to regulatory affairs, reimbursement and quality assurance, both domestic and international.
- Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public.
- Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
- Ability to read and synthesize technical material and to prepare clear and concise written documents.
- Comprehensive knowledge of US Good Clinical Practice (GCP), ISO 14155-2011 (GCP), Good Manufacturing Practices (GMP), Quality Systems Management (ISO 13485) and Good Laboratory Practices (GLP) requirements,
- Demonstrated experience in client service in the clinical research business.
- Demonstrated ability to motivate, lead, and grow a regulatory affairs team.
- Extensive demonstrated experience directing and supervising staff.
- Demonstrated high energy level.
- Ability to handle multiple tasks and challenges simultaneously.
- Demonstrated ability to form strong working relationships across functional boundaries.
- Excellent written and verbal communication skills.
- Excellent negotiation skills.
- Exceptional ability to conceptualize, develop and manage timelines.
- Ability and willingness to travel internationally.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Ability to travel internationally
- Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
- A minimum of 5 years of experience in clinical R&D and/or clinical research organizations focused on regulatory affairs.
- Advanced degree in biomedical sciences and/or business management or comparable years of experience.
- Excellent demonstrated knowledge of issues affecting regulatory affairs for clinical trials are required.
- Excellent analytical and communication skills, particularly writing skills, are essential.
- Ability to travel both domestically and internationally is required.
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.
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