Zahra Hassan Hussein Sobhy

Regulatory Affairs

META region, French-Speaking Africa, Levant

. Prepare, review, analyze and consolidate all relevant and related technical information required for the approval/licensing of products.

· Responsible for the timely completion of regulatory submissions and applications and related amendments with the competent authorities.

· Collaborate with the Regulatory Team, as well as Supply Chain Management to innovatively address regulatory issues and support achievement of Regulatory Compliance.

· Collaborate with Marketing/division managers to assess and prioritize submissions to competent authorities.

· Participate in product launch activities as required.

· Keep up to date on new and proposed regulations and guidelines published by governmental regulatory authorities as they apply to products. Direct authorities’ interactions when needed.

· Ensure compliance with government regulations by providing competent authorities, with all necessary technical information relating to changes or modifications to products.

· Manage and actively update the registration tracker database/documents all products approved for sale in the region to ensure the accuracy of the information and related change initiatives.

· Ensure all regulatory activities involving the importing and distributing of products are in compliance with the respective regulations.

· Lead and/or conduct proactive PharmacoVigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans

· Performs duties as a Safety Strategy and Management Team (Sat) leader

· Produces evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data

· Collaborates with head-quarter and Clinical representatives and authors the Reference Safety Information (RSI) for assigned development products; coordinates meetings and tracks timeliness to ensure completion

· Pro-actively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources to establish the safety profile of drugs and manage the risk to patients

· Provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timeliness

· Implementation of local SOPs of the Middle East region

· Implementation , design, and conduct Pharmacovigilance trainings.

Regulatory Affairs

META region, French-Speaking Africa, Levant

. Ensuring that a company's products comply with the regulations of the region

. Keeping up to date with international legislation, guidelines, and customer practices in all countries that the company is exporting to

. Collecting, and evaluating scientific data that has been researched by colleagues

. Developing and writing clear arguments and explanations for new product licenses and license renewals

. Preparing submissions of license variations and renewals to strict deadlines

. Monitoring and setting time-lines for license variations and renewal approvals

. working with specialist computer software and resources.

. writing clear, accessible product labels and patient information leaflets

. Planning and developing product trials and interpreting trial data

. Providing strategic advice to senior management throughout the development of a new product.

. Project managing teams of colleagues involved with the development of undertaking and managing regulatory inspections

. Reviewing company practices and providing advice on changes to systems

. Liaising with, and making presentations to, regulatory authorities

. Negotiating with regulatory authorities for marketing authorization

. Specifying storage, labeling and packaging requirements.

. New products; registration as per sales and marketing strategy

Pharmacovigilance

. Organize, manage and maintain a highly compliant Pharmacovigilance (PV) system

• Maintain awareness and ensure adherence to established and updated local and global processes and

guidelines as well as national and international regulations and guidelines for pharmacovigilance.

• Ensure PV business continuity and after hours availability.

• Lead and coordinate internal and external PV audits and inspections.

• Monitor PV system performance and compliance of partners and distributors.

• Accountable for all strategic PV activities for MEA.

• Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the

safety profile of Emmaus Medical products and to meet regulatory requirements.

• Act as the responsible contact person in the region, internally and externally, for safety-related aspects

and PV.

• Ensure internal regulatory/PV processes and procedures are well documented and support compliant

regulatory/PV activities.

META Region

. Ensuring that a company's products comply with the regulations of the Medicines and Healthcare products Regulatory Agency.

. Keeping abreast of international legislation, guidelines, and customer practices in all countries that the company is exporting to pack management activities, including compliance to local Labelling Requirements and processing pack changes on ALPIN, when required.

. Oversee review and approvals of promotional materials to provide regulatory input and guidance across the Affiliate, and obtain Regulatory Authorities’ clearance when necessary

. As applicable, provide oversight of shipment clearance/QA release of Affiliate materials/products.

. Support local market access activities from a regulatory perspective.

. . Preparing submissions of license variations and renewals to strict deadlines.

. Monitoring and setting timelines for license variations and renewal approvals.

. Working with specialist computer software and resources.

. Undertaking and managing regulatory inspections.

. Reviewing company practices and providing advice on changes to systems.

. Perform Individual Case Safety Report (ICSR) quality control (QC) Close processed ICSRs.

. Report spontaneous ICSRS to Health Authority - create a hard copy template for the PV .

. Report Suspected Unexpected Serious Adverse Reactions to Health Authorities, ECs and investigators - create a hard copy template for the PV Associate to adapt and distribute.

. Perform ICSR reconciliation with business partners, and track ICSRs.

. Write or contribute to PSURs and ASRs as required. This may include acting as the project . coordinator, collating the needed information, incorporate reviewers' comments and finalizing the document.

. Assist with Pharmacovigilance processes, supporting the preparation of SOPs, product safety reviews and literature reviews as required.

. To review literature screening search results, identifying ICSRs and other safety-related findings.

. Arranging appointments with doctors, pharmacists, and hospital medical teams, which may include pre-arranged appointments or regular 'cold' calling

. Making presentations to doctors, practice staff and nurses in GP surgeries, hospital doctors and pharmacists in the retail sector. Presentations may take place in medical settings during the day or may be conducted in the evenings at a local hotel or conference venue

. Organizing conferences for doctors and other medical staff

. Building and maintaining positive working relationships with medical staff and supporting administrative staff

. Managing budgets (for catering, outside speakers, conferences, hospitality, etc.)

. Keeping detailed records of all contacts

. Reaching (and if possible exceeding) annual sales targets

. Planning work schedules and weekly and monthly timetables. This may involve working with the area sales team or discussing future targets with the area sales manager. Generally, medical sales executives have their own regional area of responsibility and plan how and when to target health professions.

. Regularly attending company meetings, technical data presentations, and briefings

. Keeping up to date with the latest clinical data supplied by the company, and interpreting, presenting, and discussing this data with health professionals during presentations

. Monitoring competitor activity and competitors' products.

. Maintaining knowledge of new developments in the National Health Service (NHS), anticipating potential negative and positive impacts on the business, and adapting strategy accordingly.

. Developing strategies for increasing opportunities to meet and talk to contacts in the medical and healthcare sector.

. Staying informed about the activities of health services in a particular area.

Dubai, UAE

. Arranging appointments with doctors, pharmacists and hospital medical teams, which may include pre-arranged appointments or regular 'cold' calling

. Making presentations to doctors, practice staff and nurses in aesthetic clinics and centres, . Presentations may take place in medical settings during the day or may be conducted in the evenings at a local hotel or conference venue

. Making demonstration on volunteer for dermatology doctors with company devices to see the results life

. Organizing conferences for doctors and other medical staff

. Building and maintaining positive working relationships with medical staff and supporting administrative staff, and biomedical engineers

. Managing budgets (for catering, outside speakers, conferences, hospitality, etc.)

. Keeping detailed records of all contacts

. Reaching (and if possible exceeding) annual sales targets

. Planning work schedules and weekly and monthly timetables. Generally, medical sales executives have their own regional area of responsibility and plan how and when to target health professions.

. Regularly attending company meetings, technical data presentations, and briefings

. Keeping up to date with the latest clinical data supplied by the company, and interpreting, presenting, and discussing this data with health professionals during presentations

. Monitoring competitor activity and competitors' products.

. Developing strategies for increasing opportunities to meet and talk to contacts in the medical and healthcare sector.

. Staying informed about the activities of health services in a particular area.

Key account manager

. Arranging appointments with doctors, and hospital medical teams, which may include pre-arranged appointments or regular 'cold' calling

. Making presentations to head of department doctors, Presentations and demonstration may take place in medical settings during the day or may be conducted in the evenings at a local hotel or conference venue

. Attending operations with key account doctors with a sample of our biological products, and follow up with the patients’ health evaluation for 1-month post operation

. Organizing conferences for doctors and other medical staff

. Building and maintaining positive working relationships with medical staff and supporting administrative staff

. Managing budgets (for catering, outside speakers, conferences, hospitality, etc.)

. Keeping detailed records of all contacts

. Reaching (and if possible exceeding) annual sales targets

. Planning work schedules and weekly and monthly timetables. This may involve working with the area sales team or discussing future targets with the area sales manager. Generally, medical sales executives have their own regional area of responsibility and plan how and when to target health professions.

. Regularly attending company meetings, technical data presentations, and briefings

. Keeping up to date with the latest clinical data supplied by the company, and interpreting, presenting and discussing this data with health professionals during presentations

. Monitoring competitor activity and competitors' products.

. Developing strategies for increasing opportunities to meet and talk to contacts in the medical and healthcare sector.

. Staying informed about the activities of health services in a particular

. Review scientific and legal documents.

. Gathering, evaluating, organizing, managing, and collating information in a variety of formats

. Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency maintaining familiarity with company product ranges

. Planning, undertaking, and overseeing product trials and regulatory inspections

. Keeping up to date with changes in regulatory legislation and guidelines

. Analyzing complicated information, including trial data

. Offering advice about company policies, practices, and systems

. Obtaining marketing permission

. Outlining requirements for labeling, storage, and packaging

. Using a variety of specialist computer applications

. Liaising and negotiating with regulatory authorities

. Providing advice about regulations to manufacturers/scientists

. Writing comprehensible, user-friendly, clear product information leaflets and labels

Ensuring that quality standards are met, and submissions · meet strict deadlines

· Preparing documentation.

Responsible for conducting primary and secondary research to investigate different medical diseases and concluding them for further process and product improvements

§ DATA GATHERING: Gathering, and collecting medical information and patient cases about the efficacy of some drugs in managing diseases, especially chronic diseases

§ MEDICAL FIELDS INVESTIGATION: The medical fields under my investigations are:

- Cardiology: Hypertension, MI, Angina

- Oncology: Renal cell carcinoma, especially stage four

- Gynecology and Obstetrics: Deep venous thrombosis in pregnancy

- Endocrinology: Type-2 diabetes mellitus

§ INTERVIEWS: Conducting face to face interviews to collect medical information done with a wide variety of doctors, and professional in all the above-stated fields

§ DATA MANAGEMENT: Conducting data entry, data analysis after data collection, using the world health organization (WHO) coding system, for both the diagnosed diseases and drug therapy used in the treatment.

• Dispensing prescription medicines to the public.

• Ensuring that different treatments are compatible.

• Checking dosage and ensuring that medicines are correctly and safely supplied and labeled (pharmacists are legally responsible for any dispensing errors).

• Keeping a register of controlled drugs for legal and stock control purposes.

• Liaising with doctors about prescriptions.

• Selling over the counter medicines.

• Counseling and advising the public on the treatment of minor ailments.

• Advising patients of any adverse side-effects of medicines or potential interactions with other medicines/treatments.

• Managing a needle and syringe exchange.

• Monitoring blood pressure and cholesterol levels.

• Offering a diabetes screening service.

• Arranging the delivery of prescription medicines to patients.

• Managing, supervising, and training pharmacy support staff.

• Budgeting and financial management.

Keeping up to date with current pharmacy practice, new drugs, and their uses.

§ RESEARCH: Conducting research in Psychiatry to find out the certain hypothesis

§ DATA COLLECTION: Gathering and collecting medical information, about the efficacy of some drugs in managing diseases

§ FACE TO FACE INTERVIEWS: Face to face interviews with doctors and professionals

Enduring Contribution:

§ PRODUCT PROMOTION: Promoting drug company medicines and products, via face to face visiting the company specified doctors in different areas of Egypt

§ PRESENTATION SKILLS