Akram Hatem
Head Of Information Management, Global Regulatory Affairs Operations
Munich
Summary
Accomplished leader with over a decade of experience in direct reporting, matrix, and project leadership roles within the pharmaceutical industry. Specializing in Regulatory Affairs, successfully leading diverse functions and regions, while contributing to Operations, Quality, Business Development, M&A, and Product Development. Earned a Doctorate Degree in 2018, focusing on leveraging digital technologies to enhance pharmaceutical companies' competitive edge. Active member of the Harvard Business School expert circle and the Harvard Business Review Advisory Council, engaging in discussions on new products, attending leadership events, and providing insights on industry trends such as AI solutions for improved sales and customer satisfaction. Strategic contributions to regulatory compliance, commercial operations, and successful digital solutions implementation like Veeva Vault. Led significant work-streams in spin-offs of Pfizer Animal Health and establishing Zoetis, Bayer Animal Health spin off & acquisition & integration in Elanco, and spon off Sandoz from Novartis.
Overview
14
14
years of professional experience
5
5
Languages
Work History
Head of Global Information Management, Global Regulatory Affairs Operations
Sandoz
- Current
- In Sandoz as Head of Global Information Management, Global Regulatory Operations, I worked with my 5 team leads and 60 team members to build the Information Management function and seek new technologies that will better support us to comply with regulations and improve time to market.
- In addition, I have worked with the team on building the function, including P&L, business cases for choosing locations where it best serves the purpose, putting clear vision, mission, objectives and KPIs for the function and work on its branding and positioning as business partner that can support different stakeholders in preparing and making the submissions.
Head of Global Business Process Excellence, Global Regulatory Affairs Operations
Sandoz
- Current
- Working previously as Head of Global Business Process Excellence in Sandoz, Global Regulatory Operations, I worked with my team of 10 direct reports of team leads and project managers and 39 team members to drive projects that are going to improve the technological aspects in Sandoz based on the external environment trends.
- I had the responsibility of RA QA and compliance within my function, in addition to RIM project teams. Big part of my responsibility in as Head of Business Process Excellence still carried within my responsibilities as Head of Information Management.
Director, Regulatory Affairs Europe (non-EU), Middle East and Africa
Bayer Animal Health GmbH/Elanco
- Current
- During my previous role as Regional Regulatory Affairs Director for Europe (non-EEA), Middle East and Africa region based in Monheim, Germany, I was responsible for leading a team of 35 individuals located in 15 countries and speaking 10 different languages to achieve organization objectives.
- In addition, I lead the region restructuring, dividing it into subregions to bring more focus and prioritization to the team and work with the team leads to choose the best locations where the team members should be located.
- I was able to create a cross functional committee with different stakeholders internally with representatives from Business, project management, customer support and Supply Chain to ensure that all functions are aligned on the timelines and progress to support getting products into market in the least possible time frame.
Regional Regulatory Affairs Manager; Eastern Europe, Middle East and Africa
Bayer Animal Health GmbH
03.2017 - 01.2021
- Collaborated with cross-functional teams to assess product changes and determine regulatory impact on market strategies.
- Actively monitored industry trends and regulatory changes, adjusting internal policies accordingly to maintain compliance.
- Coordinated audits with external regulatory bodies, preparing necessary documentation and facilitating communication between stakeholders.
- Prioritized project-related tasks to efficiently complete essential tasks.
Regulatory Affairs Manager, Middle East Region
Zoetis
04.2014 - 02.2017
Regulatory Affairs Associate Manager
Zoetis
01.2014 - 04.2014
Logistics and Regulatory Specialist, Egypt and Middle East
Zoetis
03.2011 - 01.2014
Education
Bachelor's - veterinary medical sciences
Cairo University
CairoLeadership and Management Specialty Certificate - undefined
Harvard Business School-Online
Doctoral of Business Administration (DBA) - Major General Management
Arab Academy for Science, Technology and Maritime Transport
01.2013 - 1 2018
Master of business administration (MBA) - Major marketing
Arab Academy for Science, Technology and Maritime Transport
Project Management Diploma - undefined
Regional Information Technology Institute
Zamalek, Cairo 05.2010 - 8 2010
Skills
Leadership
Interests
Hiking
Former Traditional Taekwondo Player
Reading
Travelling
Formal Recognitions
- Joining the advisory council of Harvard Business Review magazine, 2024
- Recognized by Harvard Business School as one of their business experts, 2022
- Invited to join in person or virtually the Harvard Business School Connext event, 2024
- Recognized in Pfizer as the one who made the biggest overall improvement in the Regulatory Affairs function, 2013
- Recognized in Bayer by 'Top Performance Award' and 'Exceptional Performance Awards', 2018-2021
- Member of German Association for Regulatory Affairs (DGRA)
Major Project Contributions
- Participating as part of the team spinning off Bayer Animal Health from Bayer AG, Responsible to work with the team to separate the big 50 countries globally and organize the integration plans with Elanco thereafter.
- Bayer Animal Health spin off project, 2nd one after contributing to the spinoff of Pfizer Animal Health from Pfizer.
- Recent contribution to my 3rd spin off of Sandoz from Novartis.
Current Job
Head of Global Information Management, Global Regulatory Affairs Operations, Sandoz, Worked with my 5 team leads and 60 team members to build the Information Management function and seek new technologies that will better support us to comply with regulations and improve time to market.
Previous Jobs
- Head of Global Business Process Excellence, Global Regulatory Affairs Operations, Sandoz
- Director, Regulatory Affairs Europe (non-EU), Middle East and Africa, Bayer Animal Health GmbH/Elanco
- Regional Regulatory Affairs Manager; Eastern Europe, Middle East and Africa, Bayer Animal Health GmbH, 03/2017 to 08/2020
- Regulatory Affairs Manager, Middle East Region, Zoetis, 04/2014 to 02/2017
- Regulatory Affairs Associate Manager, Zoetis, 01/2014 to 04/2014
- Logistics and Regulatory Specialist, Egypt and Middle East, Zoetis, 03/2011 to 01/2014
- Communication Manager, Avian Influenza Emergencies Management Unit, General Organization for Veterinary Services, 10/2010 to 03/2011
- Project Communication Manager, SAIDR, USAID funded Project, 03/2010 to 09/2010
Professional Courses
IICAB training, IOWA State University, 19 to 23 May 2014, Medicademy Veterinary Regulatory Affairs in Europe, Denmark, 12 to 14 April 2016, Certified Regulatory Affair Professional, Copenhagen University, 05/23/16, WIGS training course (manager's certification), Stephen Covey Organization, Stop Micromanaging: Improve your Team's Problem-Solving Skills, Simon Sinek Organization, Clear Communication: How to ask for what you need, Simon Sinek Organization, Emotional Intelligence: The one Trait your Team needs from you Right Now, Simon Sinek Organization, 5 Ways to create Independent, Empowered Employees, Simon Sinek Organization, Addressing Poor Performance, online course, Advanced Coaching, online course, Coaching for peak performance, online course, Coaching: Move People Forward, online course, Communication: Connect Through Conversations, online course, High Impact Feedback and Listening, online course, Situational Leadership Skills I, online leader led training, Situational Leadership Skills II, online leader led training, Leadership in Strategic Health Communication 'Special Focus on Family Health', Johns Hopkins University Bloomberg School of Public Health, Center for Communication Programs, 36 hr course
Military Status
Exempted
Personal Information
- Passport Number: Valid
- Date of Birth: 05/04/87
- Nationality: German
- Driving License: Valid
- Marital Status: Married
- Place of Birth: Cairo
Affiliations
Harvard Advisory Council
Timeline
Regional Regulatory Affairs Manager; Eastern Europe, Middle East and Africa
Bayer Animal Health GmbH
03.2017 - 01.2021
Regulatory Affairs Manager, Middle East Region
Zoetis
04.2014 - 02.2017
Regulatory Affairs Associate Manager
Zoetis
01.2014 - 04.2014
Doctoral of Business Administration (DBA) - Major General Management
Arab Academy for Science, Technology and Maritime Transport
01.2013 - 1 2018
Logistics and Regulatory Specialist, Egypt and Middle East
Zoetis
03.2011 - 01.2014
Project Management Diploma - undefined
Regional Information Technology Institute
05.2010 - 8 2010
Head of Global Information Management, Global Regulatory Affairs Operations
Sandoz
- Current
Head of Global Business Process Excellence, Global Regulatory Affairs Operations
Sandoz
- Current
Director, Regulatory Affairs Europe (non-EU), Middle East and Africa
Bayer Animal Health GmbH/Elanco
- Current
Bachelor's - veterinary medical sciences
Cairo University
Leadership and Management Specialty Certificate - undefined
Harvard Business School-Online
Master of business administration (MBA) - Major marketing
Arab Academy for Science, Technology and Maritime Transport
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