IQVIA Regulatory Affairs Specialist (Home-Based) - IQVIA Biotech in Cambridge, Massachusetts
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Please note this position is NOT related to study start-up but rather regulatory affairs dealing with applications to government authorities.
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.
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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
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 firstname.lastname@example.org to arrange for such an accommodation.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.
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