(Senior) Regulatory Affairs Specialist (Home-Based) - IQVIA Biotech

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

BASIC FUNCTIONS:

To provide regulatory and quality support for assigned clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures.  The responsibilities may include preparation of FDA meeting requests, meeting packages, preparation of responses to FDA questions, management, preparation and submission of initial IND applications and IND amendments to the US FDA. Preparation of CMC modules (small molecules and biologics both) of regulatory applications. 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.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agency(ies) to the project team.
• Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
• Leads the preparation, submission and maintenance of regulatory filings with relevant health authorities
• Write/compile, and review high-quality CMC modules for development applications, and amendments, for submission, ensuring complete CMC content that meets current regional requirements and FDA/EU/World Health Authority requirements.
• Leads and supports multidisciplinary teams in the development and authoring of major regulatory documents such as initial IND applications, IND amendments, meeting requests, meeting packages and IMPD etc. 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. 
• Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated IQVIA Biotech activities, as appropriate.
• Serve as IQVIA Biotech liaison with central IRBs.
• Perform other related duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

• Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international.
• Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking.
• Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards.
• Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems.
• Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports.
• 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.
• Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Ability to travel domestically and internationally 20%
• Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:

• Requires Bachelor's degree with at least 3 years of related work experience, with 2 or more years in regulatory affairs, quality assurance and/or clinical research, or equivalent level of education, training and experience.
• Science degree preferred.
• Excellent analytical and communication skills, particularly writing skills, are essential.
• Must be familiar with and able to identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory bodies. 
• Must be able to independently coordinate with interdisciplinary team members, manage timelines for and compile documents for pre-IND and IND submissions, with oversight from Regulatory Management.
• Demonstrated Clinical, Pre-clinical and or CMC knowledge for chemical or biologic products preferred.
• Demonstrated computer literacy is required. 

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

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Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

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 workday_recruiting@iqvia.com to arrange for such an accommodation.