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Regulatory Affairs Manager Resume Sample, Experience : 14 years

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Biodata

Name of the Candidate:[Private]
Name of the Post Applied:Regulatory Affairs Manager
Job related skills / software:Comprehensive knowledge of medical writing and analyzing complex medical data,Knowledge of e-learning and publication development
Category:Medical
Sub Category:Drug Regulatory Affairs Executive
Years of Experience:14 years
State:Haryana
Gender:Female
Salary Expected per Month(Rs):Negotiable
Highest Qualification attained:M.Sc. / MSC : Master of Science
Major / Specialization:Pharma
Email Id:[Private]
 
Are you looking for job now?:Yes
Can the recruiter contact you?:Yes
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Resume Format / CV Sample Template / Example / Model :

    

Email Address : hana102moh AT hotmail.com
Date of Birth : 22 November 1979
Nationality : Egyptian
Qualification : Master's degree, Clinical Pharmacy Ain Shams University Egypt 2015.
Current position : Regulatory Affair & Exportation Assistant manager
Region of responsibilities. Gulf, Saudi Arabia, Jordan, Sudan, Yemen, Iraq, Libya, Uganda, Tanzania, Ethiopia, Niger and Cameroon.
Current city of living. Cairo, Egypt.

CAREER OBJECTIVES :
Interested in developing expertise in the fields related to my studies. It is thus my desire to utilize my scientific, pharmaceutical, communication and computer skills in the best possible way for achieving the company’s goals as Regulatory Affairs Manager through utilizing my experiences in scientific data research and collection.

Competencies  :
** Nine years of progressive experience in pharmaceutical industry
** Comprehensive knowledge of medical writing and analyzing complex medical data
** Knowledge of e-learning and publication development
** Good communication and interpersonal skills
** Ability to succeed in a fast and commercial working environment
** Strong organizational, motivational and organizational skills
** Flexible and willing to travel internationally
** Ability to work as a part of a team and independently
** Ability to guide and convince client as well as colleagues in therapeutically areas
** Keep up to date with market trends and new developments utilizing information for business improvement
** Understand and develop long term business vision
** Careful delegation of tasks whilst maintaining responsibility for final result
** Careful planning to achieve accurate and timely results
** Ability to discuss strategic and sensitive issues
** Recognize recurring issues and analyze their causes in order to reach a solution

EDUCATION :
Ain Shams University 2015 Cairo, Egypt Clinical Pharmacy, Master Degree (MD), GPA : very Good
Cairo University 2005 Cairo, Egypt Diploma in Hospital Pharmacy GPA : very good
Ain Shams University 2002 Cairo, Egypt Clinical pharmacy, Bachelor(BSc/BA), GPA : very Good

WORK EXPERIENCE :
November 2006 – Present Egyphar Cairo, Egypt Regulatory affair & Exportation Assistant Manager
Region of responsibilities : Egypt, Gulf, Saudi Arabia, Jordan, Sudan, Yemen, Iraq, Libya, Uganda, Tanzania, Ethiopia, Niger and Cameroon.

Nine years' experience as Regulatory affairs associate handling the following :
** Responsible for coordination & preparation of regulatory submissions and strategies new registration preparation, submission, renewal preparation, submission, variation preparation submission and manufacturer full registration.
** Provided regulatory and guidance to Manufacturing, Validation, Quality Control, Quality Assurance, Supply and Logistics, Project Management, Stability and Clinical colleagues.
** Manage the final product files submissions and communicate effectively with regulatory authorities of the region of responsibilities through our co promoters in these regions to obtain timely product approvals.
** Manage transposition of international standards into company product related requirements.
** Implement QA systems and generate SOPs.
** Update licensing and collect information on registration instructions and regulations.
** Pharmacovigilance and RMP knowledge and training.
** Change control.
** Prepared and coordinated EDA, ICH, FDA, EU, TFDA, NDA and S
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FDA guidelines and regulations experienced CTD, eCTD and to other global regulators.
** Reviewed documents including clinical study reports, labeling drafts and validation and stability protocols and reports.

April 2003 – April 2008 Heliopolis Psychiatric hospital Cairo, Egypt Pharmacy manager :
Five years as Pharmacy manager Handling the following :
** Improve operational and financial pharmacy performance at all facilities within a hospital to include but not limited to : medication safety, patient safety, resource utilization, financial reporting, performance improvement,
** Use of technology, regulatory compliance, drug utilization, clinical education and staff development, management of appropriate drug utilization, drug spend analysis and quality improvement in order to provide quality healthcare to patients within hospital
** Participate in the development, implementation, and evaluation of policies, procedures, and standards of practices affecting patient care consistent with departmental and regulatory objectives
** Guide individuals and groups towards desired outcomes, setting high performance standards and delivering quality outcomes
** Establish and maintain long-term relationships, building trust and respect by consistently meeting and exceeding expectations
** Articulate knowledge and understanding of organizational policies, procedures, and systems
** Manage employee performance by providing recognition, coaching, feedback, and implementation of the performance improvement process when necessary
** Meet and exceed monthly pharmaceutical cost savings by implementation of corporate clinical initiatives and streamlining pharmacy workflow
** Prepare, recommend, and coordinate the development of personnel, pharmaceutical, and capital budget based on departmental needs and requirements
** Develop and maintain close relationships within the interdisciplinary team in order to affectively meet hospital and pharmacy goals and initiatives
** Oversee the Pharmacy and Therapeutics Committee meeting in collaboration with the Physician Chairperson
** Remain current with laws governing pharmacy in Illinois and ensure policies, standards, and practice within the designated clinical divisions are in compliance and consistent with the goals of the organization
** Plan, organize, direct, and controls the operation of the pharmacy department effectively and delegate responsibilities to appropriate personnel
** Interacts with all levels of the hospital organization in the effort to enhance the pharmacy operations
** Possess the innovative/problem solving skills necessary to develop, evaluate, and analyze patterns in an effort to strategically plan for future initiatives
** Work within the confines of budget and staffing constraints by identifying and analyzing trends as well providing employees the skills and opportunity to enhance their knowledge and facilitate new methods to enhance their professional growth

June 2002 – April 2003 Bristol-Myers Squibb Cairo, Egypt Medical Representative

IT Skills  :
Windows & Office tools
Professional user

Training Courses :
Leadership Training :
** Situational leadership
** Targeted selection.
** Conflict Management & Conflict Resolution.
** Basic Selling Skills.
** Assertive selling.
** Presentation Skills.
** Insights Training “Dealing with different Personal Characters”.
** Negotiation Skills.
** Pharmacovigilance and QPPV
** Therapeutic Drug Monitoring

LANGUAGES English : Fluent
Arabic : Native

REFERENCES  : Available upon request

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