Senior Manager Regulatory Affairs - IQVIA

Job Title: Senior Regualtory Affairs Manager/ Director

Contract: Permanent/Full-time

Department: Global Regulatory Affairs

Location: Egypt

IQVIA uses Human Data Science — the integration of data science, technology, and human science — to help customers address both current needs and future opportunities. But to get there, to make Human Data Science work, for you, you need a seamless integration of unparalleled data, advanced analytics, transformative technology, and deep domain expertise.

This role is a great opportunity for an experienced regulatory professional with broad regulatory experience and expertise to work with the world’s leading CRO. This position requires a demonstrable knowledge of operational experience in European regulatory affairs within the service industry or biopharmaceutical companies.

PURPOSE

Manages a regulatory and/or technical project, for both internal and external clients, as appropriate. Provides strategic regulatory and/or technical consultancy on a variety of projects.

RESPONSIBILITIES

• Acts as a Lead Regulatory Professional on any type of writing or technical project, with limited guidance from senior staffusing experience and initiative to generate new and unusual document types to meet customer requirements.
• Provides strategic regulatory and/or technical consultancy on a variety of projects and provides senior review andguidance for most documents prepared by junior colleagues.
• May act as a Project Manager for a stand-alone project, with full project management responsibility.
• May prepare a single service regulatory or technical proposal for senior review and/or propose budgets for less routineprojects, out of scope activities and potential budget efficiencies. Deliver business development presentations tocustomers with confidence and detailed knowledge, as directed.
• Independently meet with customers face to face to discuss project status. Identifies creative solutions to challenges thatare acceptable to IQVIA and customers, thereby consistently receiving positive customer feedback.
• Ensures compliance with regulatory processes, ensuring readiness for internal or external project audit.
• May design training materials and deliver training externally and internally.
• May represent region or site on a regulatory, technical or cross functional Initiative.
• Performs other tasks or assignments, as delegated by Regulatory management.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Extensive experience in regulatory and/or technical writing
• Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers
• Strong software and computer skills, including MS Office applications
• Sets a positive example to more junior colleagues relating to a professional manner, positive attitude and communication style with customers and colleagues
• May take calculated risks when making decisions, seeking guidance from Regulatory management, as appropriate; demonstrates autonomy and initiative, as appropriate
• Ability to earn respect from peers in other operational groups

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Degree in life science-related discipline or professional equivalent plus at least 6 years relevant experience* including 4 years regulatory experience or high school diploma plus 10 years relevant experience* including 6 years regulatory experience (*or combination of education, training and experience)

What you can expect from IQVIA: 

At IQVIA, you have the opportunity to make a lasting impact on our customers, the industry, patient health around the world, and your career. We are committed to rewarding your contributions with a combination of competitive salaries, comprehensive benefits, and an award-winning culture.

Next steps:

You will be contacted by one of our recruiters to arrange a prescreen call should your background be relevant for this opportunity who will be able to give you more information on this team and the opportunity and also explain the assessment process to you for this role.

Apply Here