Mohammed Jobran
Regulatory Affairs Consultant, SFDA.
Riyadh
Summary
20 years of regulatory experience working for the SFDA and the Pharmaceutical industry. Successfully managed mega regulatory projects such as multinational mergers & acquisitions, the establishment of new pharma and medical device manufacturers, Tech Transfers/localisation, technical file development (eCTD, MDD/MDR TFA), in/out-licensing of portfolios, and others. Unique access abilities to the SFDA, MOH, MOHAP, and other GCC authorities. Managed joint projects with top pharma and MedTech companies such as: Pharma: Novartis, GSK, Astra Zeneca, MSD, Abbot, Amgen, and more. MedTech: PDI, SECA, SNIBE, ZOLL, Essilor, Quanta Systems, and more. Author and creator of new due diligence and gap analysis methods for products and entities. Advise with an innovative and visionary opinion in regulatory strategies (time, cost, & efficiency). Experienced with a wide range of RA projects and submission types as a firsthand implementor. High knowledge of regulations, RA intel, and industry dynamics. Excellent communication skills with global business offices and local commercial partners.
Overview
20
20
years of professional experience
Work History
Principal Consultant, Regulatory Affairs. Founder
PharmaKnowl Consulting
Riyadh
12.2019 - Current
- 20 years of regulatory experience working for the SFDA and the Pharmaceutical industry.
- Successfully managed mega regulatory projects such as multinational mergers & acquisitions, the establishment of new pharma and medical device manufacturers, Tech Transfers/localisation, technical file development (eCTD, MDD/MDR TFA), in/out-licensing of portfolios, and others.
- Unique access abilities to the SFDA, MOH, MOHAP, and other GCC authorities.
- Managed joint projects with top pharma and MedTech companies such as: Pharma: Novartis, GSK, Astra Zeneca, MSD, Abbot, Amgen, and more. MedTech: PDI, SECA, SNIBE, ZOLL, Essilor, Quanta Systems, and more.
- Author and creator of new due diligence and gap analysis methods for products and entities.
- Advise with an innovative and visionary opinion in regulatory strategies (time, cost, & efficiency).
- Experienced with a wide range of RA projects and submission types as a firsthand implementor.
- High knowledge of regulations, RA intel, and industry dynamics.
- Excellent communication skills with global business offices and local commercial partners.
- End-to-end regulatory services from product development to market launch.
- New entity legal setup and new market entry projects.
- Development of RA strategic plans with hands-on implementation.
- Drug registrations & life cycle management.
- Regulatory intelligence with valuable insights and interpretations.
- Cross-functional support (quality, commercial, medical, marketing, Supply Chain, and others).
- PV services: Outsourcing and development of Saudi PV system (PSSF), QPPV, & literature review.
Scientific Office and Regulatory Affairs Manager
Aspen Pharmacare
12.2013 - 12.2019
- Managed multiple MA transfer projects of +70 drugs in Saudi under 5 global acquisitions with a high level of communication and collaboration with local and international partners.
- Achieved an outstanding number of successful drug price increases with a total of 9 drug increases in SFDA and 5 central price increases at the unified GCC pricing council. That included planning, analysis, submission, and lengthy authority negotiations.
- Managed successfully to challenge and influence the authority into cancelling a decision to reformulate the company’s best-selling drug.
- Involved in business development projects related to regional acquisitions and licensing projects.
- Crisis management of a couple of withdrawals and other drastic regulator decisions.
- Negotiated and secured an exceptional approval to reroute a 2M EUR worth of goods.
- Resolved many commercial challenges with the company’s local distributors.
- Implemented the serialization (Track & Trace) project.
- Built and implemented a local Pharmacovigilance system (Saudi PV sub-system file).
- Recruitment, management, and mentoring of regulatory and PV teams.
Pharmacovigilance Manager
Aspen Pharmacare
01.2016 - 12.2019
- Registered several pharmaceutical products, including oncology, biosimilar, and generics.
- Several GMP site approvals in the EU, Chile, and South Africa. Accompanying SFDA inspectors.
- Experienced with several manufacturing site transfers in the EU and locally.
- Registered a new EU MAH office in Saudi.
- Experienced in revision and approval of safety data (SPC, PIL, CCDS).
- Secured a high number of exceptional approvals, import permits, and waivers.
- Managed to clear several rejected shipments.
Acting Head, Drug Informatics Administration
Saudi Food and Drug Authority - SFDA
01.2012 - 01.2013
- Established and headed the “Drug Informatics Administration” team of 4 members.
- Continued to work on the harmonisation projects (ICH) in collaboration with EU advisors.
- Involved and managed projects related to drug application structure and its internal workflow.
- Member of the evaluation standards committee.
- Supervised the electronic systems, which are related to submission and evaluation.
- Collaborated in the building and designing of multiple regulatory software.
- Provided several training sessions to the industry and SFDA employees.
Chief Pharmacist, Regulatory Affairs Department
Saudi Food and Drug Authority - SFDA
01.2010 - 01.2013
- Regulatory revision of over 70 drug applications.
- Supervised a team of RA admins who were responsible for dossier validation.
- Contributor to several regulatory guidelines.
- Liaison with international and local gov bodies.
- Trainer for staff and industry.
- Manager of one of the Drug Sector strategic projects.
Regulatory Pharmacist
Saudi Food and Drug Authority - SFDA
01.2005 - 01.2007
- Secretary, Drug Sector Advisory Committee.
- Secretary, Pharmaceuticals Patent Committee.
- Rapporteur, Member, Drug Sector Website Committee.
- Member of the research team for “Counterfeit Drugs.”
Education
BSc - Pharmaceutical Sciences
King Saud University
01.2005
MSc - Biomedical Informatics
Nova Southeastern University
01.2010
Skills
- Regulatory Affairs
- Pharmacovigilance
- Project Management
- Leadership
- Soft Skills
Languages
Arabic
English
Personal Information
Nationality: Saudi Arabia
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse
Websites
Timeline
Principal Consultant, Regulatory Affairs. Founder
PharmaKnowl Consulting
12.2019 - Current
Pharmacovigilance Manager
Aspen Pharmacare
01.2016 - 12.2019
Scientific Office and Regulatory Affairs Manager
Aspen Pharmacare
12.2013 - 12.2019
Acting Head, Drug Informatics Administration
Saudi Food and Drug Authority - SFDA
01.2012 - 01.2013
Chief Pharmacist, Regulatory Affairs Department
Saudi Food and Drug Authority - SFDA
01.2010 - 01.2013
Regulatory Pharmacist
Saudi Food and Drug Authority - SFDA
01.2005 - 01.2007
BSc - Pharmaceutical Sciences
King Saud University
MSc - Biomedical Informatics
Nova Southeastern University
Similar Profiles
Ramanathan VenkatramanRamanathan Venkatraman
Test Manager at GDS Consulting Ernst & Young Global Consulting ServicesTest Manager at GDS Consulting Ernst & Young Global Consulting Services
Gina M. BlissGina M. Bliss
Founder at Penn Family Pharma Consulting, LLC – Bliss Compliance ConsultingFounder at Penn Family Pharma Consulting, LLC – Bliss Compliance Consulting
Anagha PaulAnagha Paul
Managing Partner at Adar Consulting, previously an affiliate of Rise One ConsultingManaging Partner at Adar Consulting, previously an affiliate of Rise One Consulting
Noura Sulaiman AlswailimNoura Sulaiman Alswailim
Brand Communication Manager at Ayen Platform CompanyBrand Communication Manager at Ayen Platform Company
Amani AlhozaimiAmani Alhozaimi
Senior Software Developer at Ministry of JusticeSenior Software Developer at Ministry of Justice