Heidi Moubarak

• Committed Regulatory Affairs and Pharmacovigilance (PV) Professional, with high attention to details, focused on meeting regulatory and PV standards and timelines.
• 5+ years of experience in both Pharmaceuticals and Medical Devices Regulatory and Pharmacovigilance activities.
• Excellent relation with government officials.
• Enthusiastic and skilled professional in the field of medical training, highly skilled in content development and creating learning programs and solutions to achieve education goals.
• Multilingual: English, Arabic, German, and French.

WORK EXPERIENCE

Schuelke and Meyr GmbH, Germany (based in UAE)

2020 - till date

• Act as a liaison between the global regulatory affairs team in Germany and the local agents in the different countries.
• Responsible for all communications with the regional agents to ensure all submissions are done accurately and in a timely manner.
• Review all the required documents for the different regulatory activities and share them with the agent.
• Provide guidance and advise on submission processes and timelines. 
• Communicate any new guidelines/ circulars shared by the agents with the global team and advise on any necessary actions.
• Maintain a track record of all regulatory activities and archive all shared documents and issued certificates.

Pharmaworld LLC, UAE

2017 - till date

• Lead the Regulatory and Pharmacovigilance department.
• Develop, implement, and maintain procedures in support of regulatory compliance.
• Assist in developing and documenting sound regulatory decisions and justifications and advise on the impact of changing regulations on the organization and on the principal companies.
• Responsible for timely application submissions on the MOHAP or Dubai Municipality Website
• Review labeling to ensure that all labeling is in accordance with local regulatory requirements.
• Ensure timely approvals by being in close contact with the health authority officials and constantly following up when necessary.
• Handle Quality Assurance by effectively reporting any quality-related cases to the principal companies as well as to the MOHAP when necessary.
• Perform RCA and CAPA 
• Author and implement standard operating procedures (SOP’s), training materials and safety practices consistent with the requirements of the local regulatory authorities.
• Perform internal audits to ensure compliance with the company’s SOP’s.
• Guide and advise on PV and regulatory requirements within the organization as well as with our principals.
• Oversee Complaint Handling, Adverse Reaction/Event Reporting and Recalls.
• Create and facilitate Regulatory Affairs and Pharmacovigilance Training for new hires and trainees.
• Review and approve Regulatory, Pharmacovigilance, Compliance and Quality agreements.

Shoppers Drug Mart Patient Contact Centre, Canada

2014 - 2016

• Supported outbound calls to patients, provided patient education and medical information so that patients resume their interrupted chronic therapy when necessary.
• Provided clinical education and answered therapeutic questions in a time efficient manner.
• Provided organizational leadership to plan and implement strategic training and development opportunities.
• Evaluated organizational training requirements and worked with other team members to design solutions optimizing onboarding, employee performance and quality management.
• Created and facilitated the New Hire training program and the Pharmacy Assistant Training program.
• Coordinated over 40 training courses to deliver high quality trainings to 400+ participants.

Pharmacy Examining Board of Canada- PEBC, Canada