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Senior Director, Global Regulatory Affairs - Europe, Middle East, Africa, Asia-Pacific

Employer
IQVIA
Location
Reading
Start date
28 Sep 2020
Closing date
28 Oct 2020

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Job Details

This role encompasses responsibilities for Regulatory Affairs in Europe (western and eastern), Middle East, Africa, and Asia-Pacific geographies. It covers regulatory affairs for all phases from drug development:  pre-clin, clinical, submission/approval/launch, and post-launch development and commercialization activities. An in-depth knowledge of the entire drug development process, as well as the EMEA health authority requirements, is essential to success. This role also oversees a staff of experienced and seasoned regulatory affairs professionals and has line management responsible for performance and development.  As a member of the GRA Lead team, they participate in the development of proposal strategy, and assignment of EU resources across projects in the GRA portfolio. The role interacts with regulatory and drug development leaders around IQVIA relative to customers who require regulatory expertise to do business in the EU and APAC market. The role also interacts with Marketing and Sales/BD across IQVIA as they generate customer requests. Finally, this role is the senior/strategic face of IQVIA to customers for IQVIA/GRA’s EMEA regulatory affairs services. Since the EU pharma market is one of the largest in the world, this requires considerable breadth of knowledge and experience.

Detailed description:

  • Leader of strategy to deliver EMEA and APAC regulatory services to customers.  In partnership with other areas of IQVIA (e.g. clinical, Strategic Drug development, IQVIA Biotech, RSU), the role requires deep understanding of customer needs and develops appropriate strategy and delivery plans for services. Key services include regulatory consulting across the product lifecycle, MAA preparation, submission and lifecycle management, HA interactions, eCTD (as appropriate) development and delivery, fulfilling EMEA requirements for life cycle management.
  • Leader of strategy to deliver EMEA regulatory services to customers around the globe (outside of EMEA). All services in the first bullet point are included, as are any accompanying Pharma  business strategies, such as mergers, acquisitions, divestments, and marketing authorization transfers. An area of high current interest is the APAC region.
  • While EU regulatory approval is often highly sought after, EU resources need to be appropriately managed, and therefore, a strong understanding of regulatory resource financials is critically important, as well as experience optimizing to meet customer expectations.
  • Capability to work collaboratively across GRA regions when customer requirements involve regulatory affairs services for products in multiple markets.
  • Capability to engage in continuous improvement of business processes, utilizing tools related to six sigma and similar methodologies.
  • Deep understanding of the regulatory technology landscape, including Regulatory Information Management (RIM) systems, Regulatory Intelligence, and platforms current used by Pharma to manage regulatory content.
  • Customer experience developing, delivering and selling regulatory services to biotech, small-, mid-, and large Pharma.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Possesses strong regulatory affairs expertise.
  • Deep knowledge of EMEA regulatory requirements across the full lifecycle of product development
  • High learning agility.
  • Strong leadership skills
  • Strong proposal management skills, as well as working effectively with cross-functional teams.
  • Excellent communication skills (oral and written), as well as interpersonal and organization skills.
  • Customer experience with delivery of regulatory services to biotech, small-, mid-, and large-pharma
  • Demonstrated ability to engage, win, and sustain customer relationships through partnership with Marketing and Sales Teams.
  • Strong software and computer skills, including MS Office applications. 
  • Strong track record of self-motivation and enthusiasm.
  • Competent with negotiation skills and is confident in making decisions with minimal supervision.
  • Ability to work on multiple projects, ensuring on-time delivery with high quality. Independently able to identify, solve and implement process improvements.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience in regulatory affairs and/or regulatory-related technology.

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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.

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