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Regulatory Affairs Manager (Home-Based) - IQVIA Biotech

IQVIA Holdings Inc.

Various Locations

Help create a healthier world: START RIGHT HERE AT IQVIA.

We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward.

Please note this position is NOT related to study start-up but rather regulatory affairs dealing with applications to government authorities.

BASIC FUNCTIONS:

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. May also include regulatory start-up activities such as 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.  Manages project scope, timelines and budgets while serving as key source of communication to senior management ensuring their awareness of project status. Work directly with Director of Regulatory Affairs, 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.  Assigned line management responsibilities.  

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Responsible for managing activities of Regulatory Affairs with emphasis on regulatory strategy

and the preparation, review and submission of documents to FDA and other regulatory authorities, including FDA meeting support.

  • Provide regulatory advice to multidisciplinary teams on the regulatory requirements to support
  • Clinical, Pre-Clinical or CMC dossier development, for example preparation and maintenance of IND and CTA fillings and EU IMPDs
  • Write, manage or oversee assembly and submission of applications to US or EU competent authorities. compile, review and approve high-quality Clinical, Pre-Clinical or 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.
  • Lead multidisciplinary teams in the development and authoring of major regulatory documents such as initial IND applications, IND amendments, meeting requests, meeting packages and EU IMPDs etc.
  • Serve as a regulatory lead as well as a Clinical, Pre-clinical or CMC project contact with external and internal clients, as needed.
  • Maintains effective communication with customer and project team through oral and written correspondence, regulatory status reports as defined. Reports progress, challenges, issues, actions and support required.
  • Directs the process for the selection of central IRBs where applicable.  Manage multiple site activation process and documentation.  Attends project meetings with cross functional department leads to provide regulatory affairs strategy.
  • Directs review and submission of essential regulatory documents for investigational product release and site activation.
  • Directs the development of Regulatory Document Management Plans (RDMP) and works to incorporate such plans with the study start up plan and Monitoring Plan in accordance with ICH/GCP and assures compliance.
  • Designs, develops, and updates Standard Operating Procedures for all US or EU regulatory affairs functions.
  • Develops budgets and is accountable for the profit/loss for regulatory affairs activities of each project and the overall performance of the regulatory affairs team.
  • Develops budgets for the regulatory affairs component of proposals in conjunction with the director of Regulatory Affairs and Global Head, Regulatory Affairs.
  • Keeps abreast of, interprets and communicates applicable regulatory agency regulations and statutes with internal departments and ensures IQVIA Biotech compliance.
  • Assures that regulatory affairs functions interface effectively with all other key operating departments within IQVIA Biotech.         
  • Works with Human Resources in recruiting and hiring qualified regulatory staff for IQVIA Biotech projects.
  • Reviews and approves reports and manuscripts, as necessary.
  • Maintains current knowledge of FDA and/or EU regulations, and GCP and ICH Guidelines for clinical research.
  • Participates in business development activities to grow IQVIA Biotech business.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Demonstrated Clinical, Pre-clinical or CMC knowledge, chemical or biologic products.
  • Demonstrated knowledge of electronic data management operations.
  • Demonstrated knowledge of quality assurance related to study startup and regulatory document collection and review.
  • Demonstrated ability to form strong working relationships across functional boundaries.
  • Demonstrated ability to motivate, lead, and grow a regulatory affairs team.
  • Demonstrated experience directing and supervising staff.
  • Experience in medicinal product and medical device regulatory affairs.
  • Experience with pharmaceutical product development.
  • Excellent knowledge of GCP/ICH guidelines for conducting clinical research.
  • Excellent written and verbal communication skills.
  • Excellent negotiation skills.
  • Exceptional ability to conceptualize, develop and manage timelines.
  • Demonstrated knowledge of resources required to permit protocol implementation.
  • Considerable ability to develop and maintain productive relationships with colleagues and other research organizations.
  • Ability and willingness to travel internationally.

CRITICALJOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Ability to travel domestically and internationally 10-15%
  • Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:

  • BS in a health-related field (i.e. nursing, pharmacy, pre-medicine, clinical research) with at least 7 years of related experience in regulatory.
  • Within the total years of experience, at least 3 years within a management role and 2 years of supervisory experience is required.
  • Masters/doctorate degrees in a related field are preferred.
  • Pharmaceutical clinical research experience and electronic data management experience are required.
  • 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.
  • Excellent demonstrated knowledge of issues affecting regulatory affairs for clinical trials are required.  Excellent written and verbal communication skills are required. 
  • Documented continuing education in regulatory affairs or Regulatory Affairs Certification preferred

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CLASSIFICATION:

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

Job posted: 2020-10-07

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