Job details
Job type full-time
Full job description
Job overview
To provide regulatory and quality support for assigned clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical proceduresTo 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 functions
Prepares, reviews and completes regulatory submissions for investigational new drug applications (inds), marketing authorization applications (maas), clinical trial applications (ctas), new drug applications (ndas), biologics license applications (blas), investigational device exemptions (ides) to united states (us) food and drug administration (fda), health canada (hc) and european as well as other regulatory authorities.
Leads and/or supports the preparation, submission, and maintenance of regulatory filings with relevant health authorities such as us fda, hc and european regulatory authorities including liaising with apac and row team.
Leads and/or supports meetings with the regulatory authorities and preparation of meeting requests, meeting packages, responses to requests for information from regulatory authorities, etc.
Writes/compiles and reviews non-clinical sections & clinical documents such as informed consent forms (icfs) for regulatory applications for global studies.
Leads and/or supports multidisciplinary teams in the development, authoring and review of high-quality chemistry, manufacturing and controls (cmc) documents for initial applications and amendments for regulatory submissions while ensuring that the contents meet current regional requirements and fda/hc/european/world health authority requirements.
Provides updates and communicates with sponsor, project manager, study start up and clinical team to anticipate, identify and resolve issues.
Assists senior management within the regulatory affairs team 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).
Identifies and interprets regulations, guidelines, and other pertinent information issued by applicable regulatory agency(ies) and other regulatory organizations.
Identifies essential regulatory documents required for execution of both domestic and global clinical research studies involving drugs, device and combination products.
Reviews protocols, consent forms, central institutional review boards (cirb) submissions, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
Ensures the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects including appropriate tracking of documents.
Serve as a member of groups, teams, or committees related to regulatory affairs, quality assurance or other designated iqvia biotech activities, as appropriate.
Perform other related duties as assigned.
Qualifications
Requires bachelor`s degree (life sciences or related focus preferred) or equivalent with at least 1-2 years of related work experience in areas relevant to regulatory affairs, quality assurance, and/or clinical research
Regulatory submissions experience (us required, canada and europe preferred), including but not limited to: pre-ind/pre-cta submissions, responses to health authority’s(ies’) questions, ind/cta submissions and ind/cta maintenance activities, including protocol amendments, development safety update reports (dsurs), cmc and/or non-clinical authoring of inds/ctas/investigational medicinal product dossiers (impds), etc
Fda submissions experience is required
Ectd experience is preferred; knowledge of publishing process is a plus
Experience in biologics, vaccines, gene therapy is a plus.
nda/bla compilation experience is a plus
Demonstrated clinical, pre-clinical and or cmc knowledge for chemical or biologic products preferred.
Equivalent combination of education, training and experience.
Must be familiar with and able to identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory authority(ies).
Must be able to independently coordinate with interdisciplinary team members, manage timelines for and compile documents, including cmc or impd, for pre-ind/pre-cta and ind/cta submissions, with oversight from regulatory management.
Excellent analytical and communication skills, particularly writing skills, are essential.
Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach.
Strong software and computer skills, including ms office applications.
Demonstrated skills in chairing small meetings.
Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision.
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 worldThe 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 wayLearn 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, incProvides reasonable accommodations for applicants with disabilitiesApplicants 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.
