Reem Zaitouni

Responsibilities:
Regulatory Affairs
- Support local/regional/global regulatory affairs projects as needed and
expand knowledge in local regulatory affairs management.
- Partner with stakeholders and document internal regulatory processes such
license renewals and registrations.
- Carry out a full cycle of registration of medical devices in MENA & SSA
countries and where applicable in accordance with the business needs of
the company aligned with in-Country and MEA QRA Management.
- Provide registration expertise to enable business growth in full compliance to policies, local laws, regulations, etc.

- Ensure preparation and submission of tender documents for MENA & SSA as
required.
- Management of post-market activities to ensure regulatory compliance.
- Manage and action regulatory intelligence with full gap assessment and
impact on the business on a timely manner.
- Review and approval of promotional material and marketing/Med Ed
activities inline with the applicable laws and SN polices/procedure.
- Ensure proper implementation of the sample management procedure and
oversee the sample room.
- Ensure completion of the MEA registration Data Base and timely updates of
the same.
- Ensure AX integration in the region to ensure regualtory complaince.
- Maintain good working relationship with MoHs/Distributors in the region and
seek to influence appropriately, with the aim of achieving optimal registrations
with minimal delay.
- Ensure compliance to the RA metrics
- Pharmacist in change for SN FZE Dubai Scientific office.
- Maintain a valid MOH license and be response on the renewal process of the pharmacist license as well as SN FZE Dubai Scientific office license.

Commercial Quality:
- Develop and maintain standard operating procedures or local working
practices.
- Responsible for management of complaints for MENA & SAA.
- Manage Quality Holds & field action process for MENA & SSA and ensure
reconciliation of product returns as part of the field action.
- Manage deviations, non-conformance report, corrective action requests, root
cause analysis and change control actions.
- Perform CAPA Root Cause, implement corrective actions and perform
effectiveness checks.
- Undertake internal audits and support in external audits -when needed- and
when completing all required trainings.
- Train employees and distributors in aspects of the quality system and
application of relevant procedures.
- Train employees and distributors in aspects of the quality system and application of
relevant procedures.

- Be on the lookout for opportunities for improvement and develop new efficient
procedures.
- Work proactively with Directors, Managers, Supervisors and Employees, to maintain a
programme of continual improvement within the areas of responsibility.
- Contribute to new business initiatives and projects and review and communicate the
impact on Quality activities for the site.

Relationship Management:
Work collaboratively, negotiate and engage with key stakeholders including the
distributors to facilitate delivery and compliance of the Quality & Regulatory
strategy within the region.

Responsibilities:

• Oversee all aspects of pharmacy operations, including prescription processing, medication dispensing, and inventory management.
• Ensure compliance with state and federal laws, regulations, and pharmacy policies.
• Provide pharmaceutical care and counseling to patients, including medication therapy management, drug interactions, and dosage adjustments.
• Address patient inquiries and concerns, offering guidance on medication use and side effects.
• Verify and dispense prescription medications accurately, adhering to dosage instructions and labeling requirements.
• Monitor and manage controlled substances following strict protocols.
• Recruit, train, and manage pharmacy staff, including pharmacists, pharmacy technicians, and support personnel.
• Conduct performance evaluations and provide ongoing training and development.
• Maintain adequate medication inventory levels, conduct regular Audit/Moh inspection , and manage medication recalls and expired products.
• Implement cost-effective inventory management practices.
• Ensure compliance with quality assurance standards, including proper storage, handling, and disposal of medications.
• Perform regular pharmacy audits and quality assessments.
• Foster a patient-centric environment, providing exceptional customer service and addressing patient needs and concerns.
• Establish and maintain positive relationships with healthcare providers and prescribers.
• Develop and implement emergency response plans to ensure patient safety in case of natural disasters or emergencies.
• Manage the pharmacy budget, including cost control, revenue generation, and financial reporting.
• Implement pricing strategies and reimbursement optimization.
• Stay updated on pharmaceutical advancements, medication therapies, and healthcare trends.
• Promote staff continuing education and training.