Ahmed Sheerah
Riyadh
Summary
Dynamic Regulatory Affairs Manager with over 20 years of experience at several pharmaceutical and health industries, excelling in risk assessment and project management. Proven track record in securing product registrations and enhancing compliance processes. Adept at staff training and fostering partnerships, driving business growth through innovative solutions and strategic collaboration.
Overview
24
24
years of professional experience
1
1
Certification
Work History
REGISTRATION ANF TECHNICAL AFFAIRS MANAGER
Abdulrahman Algosaibi Trading company
02.2025 - Current
- Developed regulatory strategies for new product submissions and approvals.
- Collaborated with cross-functional teams to ensure compliance with industry standards.
- Reviewed and evaluated product labeling for regulatory adherence and accuracy.
- Prepared documentation for regulatory submissions to government agencies.
- Monitored changes in regulations and communicated updates to relevant stakeholders.
- Conducted training sessions on regulatory requirements for staff and management.
- Managed relationships with regulatory authorities during audits and inspections.
- Assessed risks associated with product compliance and proposed mitigation strategies.
REGULATORY AND BUSINESS AFFAIRS MANAGER
DEEF Pharmaceutical Industry Co
Riyadh
06.2024 - Current
- Responsible for submitting and following up on DEEF files at SFDA, GCC (centrally), GCC states, Iraq and Yamen.
- Responsible for maintaining and life cycle management for all DEEF products at SFDA, GCC (centrally), GCC states, Iraq and Yamen.
- Selecting a good partner to enrich the company portfolio with new products.
- Engage in CMO contracts.
- Reviewed existing contracts to determine if amendments are required due to changes in regulations or other circumstances.
- Resolved disputes between the company and external parties related to contractual obligations.
- Advised management team on risk mitigation strategies pertaining to contractual issues.
- Assessed potential risks associated with proposed agreements before entering into negotiations.
- Ensured accuracy of contract documents prior to signing or execution.
- Analyzed market trends and identified opportunities for business growth.
- Developed and implemented process improvements to increase efficiency in the business affairs department.
FREE LANCER / REGULATORY CONSULTANT
Tadamun Consultant Pharmaceutical company
02.2019 - 01.2024
- Based on my 20+ years of experience, I consulted several Pharmaceutical, Medical Devise and Cosmetic companies in preparing their dossiers for submission.
- Facilitated meetings between clients, regulators, and other stakeholders to resolve disputes or negotiate settlements.
- Represented clients during negotiations with governmental agencies concerning matters related to regulation.
- Assisted clients in preparing responses required when responding to inquiries from government bodies.
- Developed comprehensive plans outlining steps necessary to comply with newly adopted regulations.
- Analyzed current processes for identifying areas of improvement relating to regulatory compliance.
- Identified potential gaps in existing regulations and proposed solutions to address them.
- Assessed client's operations for adherence to existing regulations and standards.
- Advised clients on the impact of changes in legislation or regulation on their business operations.
- Provided technical expertise during audits conducted by external auditors or government agencies.
- Collaborated closely with senior leadership teams on the implementation of company-wide initiatives related to regulatory issues.
- Communicated with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification and follow-up of submissions under review.
SCIENTIFIC OFFICE AND REGULATORY AFFAIRS DIRECTOR
Bristol Myers Squibb
01.2015 - 01.2019
- Directed all aspects of project management including planning, budgeting, staffing, scheduling, monitoring, and reporting.
- Formulated long-term objectives while managing day-to-day operations.
- Managed multiple projects simultaneously while staying within deadlines.
- Provided leadership in times of crisis or change initiatives.
SCIENTIFIC OFFICE AND REGULATORY MANAGER
Bristol Myers Squibb
06.2003 - 12.2014
- Provided advice on best practices for complying with applicable laws and regulations.
- Participated in meetings with external stakeholders such as lawyers, auditors and regulators when necessary.
- Advised senior management on potential impacts resulting from changes in local or international laws or regulations.
- I was responsible for preparing the required product dossiers for new submission, renewal and variation fillings ensure product files life cycle.
- GMP facilitators with SFDA to ensure companies comply with GMP regulations.
- Succeeded in registering the following products: 1-Baraclude 2-Abilify 3-Perfalgan 4-Reyataz 5-Onglyza 6-Kombiglyz 7-Opdivo 8-Orencia 9-Daklinza 10-Eliquis 11- Empliciti 12-Nulojix 13-Sprycel 14-Yervoy 15-Forxiga 16-Byetta 17- Bydureon.
SALES REPRESENTATIVE
Bristol Myers Squibb
07.2002 - 05.2003
- As a governmental (MOH) sales representative my responsibilities were promoting and including the following products at MOH hospital formulary: Maxipime (cefepime) the first 4th generation cephalosporin, Perfalgan (paracetamol IV) the first ready to use IV paracetamol, Abilify (Aripiprazole) for schizophrenia, Taxol (PACLITAXIL) Anticancer, Videx and Zerit for HIV.
- Communicated product features, advantages, and benefits to customers.
- Managed customer accounts by providing accurate information on product availability and pricing.
- Developed and maintained strong customer relationships and networks within designated sales territory.
- Worked with management teams to develop annual sales plans, goals, and targets.
- Conducted regular follow-ups with customers post purchase to ensure satisfaction and gauge loyalty levels.
- Called and met with regular and prospective customers to build long-term customer relationships and networks.
- Negotiated contracts and prices with clients to exceed sales goals.
Education
BACHELOR OF SCIENCE (B.S.) - PHARMACY
King Saud University
Riyadh06.2002
Skills
- Problem-solving aptitude
- Staff Training
- Employee Scheduling
- Project Management
- Risk Assessment and Management
- Teamwork and Collaboration
- Partnership Development
- Problem Resolution
Certification
Professional Registration | Pharmacist
References
References available upon request
Personal Information
Date of Birth: 04/25/78
Languages
- English
- Arabic, Native
- English, Fluent
Languages
English
Proficient (C2)
C2
Arabic
Native
Native
Timeline
REGISTRATION ANF TECHNICAL AFFAIRS MANAGER
Abdulrahman Algosaibi Trading company
02.2025 - Current
REGULATORY AND BUSINESS AFFAIRS MANAGER
DEEF Pharmaceutical Industry Co
06.2024 - Current
FREE LANCER / REGULATORY CONSULTANT
Tadamun Consultant Pharmaceutical company
02.2019 - 01.2024
SCIENTIFIC OFFICE AND REGULATORY AFFAIRS DIRECTOR
Bristol Myers Squibb
01.2015 - 01.2019
SCIENTIFIC OFFICE AND REGULATORY MANAGER
Bristol Myers Squibb
06.2003 - 12.2014
SALES REPRESENTATIVE
Bristol Myers Squibb
07.2002 - 05.2003
BACHELOR OF SCIENCE (B.S.) - PHARMACY
King Saud University