Director, Regulatory Affairs (Remote

Company: IQVIA Argentina
Location: Durham
Posted on: February 24, 2021

Job Description:

Primary Location: Durham, North Carolina, United States Additonal Locations: Cambridge, MA, USA; Overland Park, KS, USA; Parsippany, NJ, USA; San Diego, CA, USA Full time R1185729 Date Posted: 02/18/2021 Details:

---Manage a team of Regulatory Affairs professionals. ---Provide support for key regulatory activities pertaining to a project/product.
--- Interact with internal project related teams for all parts of RA aspects of a given project on clinical RA strategy or procedural aspects.
--- Participate in project/product-related discussions and provide strategic, scientific and RA input, for all parts of RA aspects of given project on clinical or procedural aspects.
--- Provide input into the asset specific regulatory strategy on a global scale.
--- Coordinate (for one or more specific sections) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities
--- For cross-product sections or stand-alone documents work with the functional regulatory groups to ensure content is aligned with targeted overall profile of the product.
--- Responsible for the delivery of high quality project/product specific regulatory documents to be submitted to Authorities and ensure that those documents meet regulatory requirements.
--- Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical and procedural and accountable for one or several of the RA aspects.
--- Act as the point of contact for Regulatory Agencies for assets ; Plan and lead activities associated with FDA meetings pertaining to a project/product
--- Be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
--- Develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities. Qualifications:--

8+ years significant experience in regulatory affairs, or appropriate relevant experience.
Ph.D Pharmacy, Chemistry, Biology or Science Degree

• Requires scientific and regulatory knowledge pertinent to development aspects, particularly Chemistry, Manufacturing & Change (CMC)
• Operational knowledge of IND, NDA/BLA regulations and experience in US regulations pertinent to product development
• Experience in liaising with major regulatory Agencies, preferably FDA and Health Canada
• Ability to manage, mentor and train direct reports.
• Demonstrated knowledge in regulatory affairs and drug/vaccine development
• In depth understanding of the required documentation to be included in NDA/BLA submissions, annual reports, CBEs
• Evidence of proactive leadership to identify issues and maximize opportunities. Ability to quickly assimilate facts and data and develop an understanding of complex matters.
• Experience in the development and licensure of drugs/vaccines in the US, Europe, and other major markets, with a special emphasis on US.
• Self-motivated with the ability to work independently, to develop credibility with colleagues within and outside IQVIA
• Ability to resolve problems through resourceful use of information and contacts
• Enterprise thinking - needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal.
• Provide input to/manage regulatory activities in order to obtain US licensure for commercial products as rapidly as possible, with the best possible label, and to maintain these authorizations.
• Determine from a strategic and scientific perspective the content of relevant sections (technical/non-clinical (NC), clinical/labelling and/or procedural) of project/product specific documents submitted to FDA (e.g. BLA, sBLA, Q&A, scientific consultations, PSPs, INDs, etc.) and ensure that these documents meet high scientific standards and regulatory requirements.
• Provide support in compiling/writing US relevant sections of meeting requests, briefing documents, orphan drug designation, expedited review, etc.
• Provide US strategic regulatory input for all development stages of the project/product within a given product portfolio to key stakeholders.
• Cover project-specific responsibilities and serve as line reviewer for US submissions to ensure adequacy and optimization where possible of US/Canada specific aspects
• Develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the FDA and Health Canada.
• Evidence of proactive leadership to identify issues and mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence
• Ability to manage individuals (including indirectly) and teams in the delivery of outputs in a timely manner
• Ability to resolve problems through resourceful use of information and contacts.
• Enterprise thinking - needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal. Preferred qualifications:
  
  --- Experience in providing strategic advice on integrated regulatory development plans with a focus on CMC, and problem solving in cross-functional teams in drug/vaccine development
  ---Ability to coordinate and execute regulatory strategy for a given project/product.
  ---Ability to assess and determine regulatory strategy for development and life cycle management programs.
  ---Strategic thinker - ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy.
  ---Ability to identify and escalate issues to and to propose mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence
  ---Proven influencing skills.
  ---Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner
  ---Ability to resolve problems through resourceful use of information and contacts.
  ---Enterprise thinking - needs to assess the potential impact on RA, including how RA may facilitate in achieving the overall goal.
  ---Quality mindset
  ---Fluent in English, with excellent writing skills.
  ---Able to input into the Company's regulatory positioning, and write /critically review key documents targeting internal or external key audiences.
  ---In collaboration with the function and regions, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions. 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.

Keywords: IQVIA Argentina, Durham , Director, Regulatory Affairs (Remote, Executive , Durham, North Carolina