Assoc Reg Affairs Dir (R1108067) in Durham, NC at IQVIA™

发布日期: 2/9/2020

职位快速浏览

  • 员工类型:
    Full-Time
  • 地点:
    Durham, NC
  • 经验:
    Not Specified
  • 发布日期:
    2/9/2020
  • Job ID:
    R1108067

职位描述

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.

IQVIA continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific professionals with business acumen who are highly motivated, collaborative, and most importantly, share our passionate to bring new medicines to patients globally.

Position Summary:

IQVIA is seeking an experienced and energetic person to manage, evaluate, and complete regulatory projects consistent with company and client goals. This position will involve assisting with Chemistry, Manufacturing and Controls (CMC) for Module 3 and/or pharmacology/toxicology (Module 2) subject matter as it relates to a wide variety of applications both for the U.S and globally. This individual will also be responsible for the timely planning, processing/preparation of regulatory submissions as well as providing support on strategy to cross-functional teams.

Essential Functions of the job:

  • With minimal supervision, plan and manage regulatory activities related to assigned projects.
  • Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
  • Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad.
  • Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents.
  • Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc. Participate on project teams and provide expertise on regulatory matters.
  • Track and assess proposed manufacturing changes for impact for IND/ANDA/NDA/BLA filings and provide submission strategies.
  • Develop and maintain current regulatory knowledge and advise management of significant developments. Work with external regulatory consultants/CRO’s as required.
  • Execute the role of U.S. Agent and/or Authorized Representative on behalf of the sponsor (communicates with FDA)
  • Participate in Agency meetings as it relates to both attendance and preparation of the documentation needed for the meetings.

Education Required: BA/BS Degree or equivalent in a health science field. RAC desired but not required.

Computer Skills: Microsoft 360

Other Qualifications:

Experience and knowledge in preparation of INDs (required) and ANDA/NDA/BLAs (desirable), and supportive amendments and supplements. Knowledge of post approval requirements is also beneficial. Experience with CTD/eCTD. Working knowledge of FDA, EMA and ICH regulatory guidance and regulations. Understanding of FDA structure and function. Knowledge/experience with regulatory requirements for other regions also desirable. Prior experience on pharmaceutical development, manufacturing, QC, or QA preferred. Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle. Excellent oral and written communications skills are a must as are superior planning skills. Strong technical writing skills. The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with IQVIA’s Code of Business Conduct and Ethics, policies and procedures.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Completes administrative tasks correctly and on time; Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations; Writes clearly and informatively; Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed; Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions and responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and within budget. Strong business acumen.

Join Us

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.



Job ID: R1108067