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Click here or scroll down to respond to this candidateCandidate's Name
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PHONE NUMBER AVAILABLEEMAIL AVAILABLEQUALIFICATIONS SUMMARYMost recent 3.5 years experience in the USA gained working as Regulatory AffairsManager in the IVD industry managing and recasting IVD devices from IVDD into IVDR and Regulatory Affairs Consultant for a Medical Device company.20 years of work experience in the pharmaceutical Industry overseeing a variety of proprietary, generic and branded generic products.Managerial experience of teams and product lines with multinational and generic pharmaceutical and medical devices companies.Profound knowledge of regulatory affairs and area management gained through responsibility for managing corporate operations in territories including Gulf countries, Middle East, Africa, Europe, Australia & NZ &Asia Pacific,.Demonstrable oral and written communication skills, comfortable with 1:1 and large group meetings as well as formal presentations, self-starter and can work independently or in a team with strong planning and organization skills.PROFESSIONAL EXPERIENCENeuMoDx/Qiagen, Ann Arbor, MichiganRegulatory Affairs Manager (May 2021-August 2023)Responsible for providing strategic and tactical support for In-vitro diagnostics (IVD) molecular diagnostic device portfolio using RT-PCRRecast and implement the update of technical documentation from IVDD to IVDR.Serve as RA lead on assigned project teams providing regulatory expertise and guidance during the design and development stages of IVD products, including reviewing and approving design control documentation (DHF),DMRs, IFUs and labelling.Lead and/or support filing activities for renewal of CE IVDD Certificates and recast for IVDR Class A, B, C and D products submissions. This includes preparing Technical Files Documentation, Design Dossiers, Regulatory Strategy Plans, General safety and Performance Requirements (GSPRs), Common Technical Specifications.Lead device related Notified Body (NB) interactions and communications throughout review period.Successful IVDR submission and approval of NeuMoDx HPV test Strips (RT-PCR test) by BSI.Formal communication and notification to NBs of changes and updates to marketed products to maintain compliance with IVDD/IVDR requirementsIdentify and manage issues and opportunities that impact submissions timelines and ensure appropriate communication, resolution and/or escalation as needed.Ensure regulatory plans are monitored, progress/variance communicated to Management and any risks are highlighted.Excellent knowledge of the EU IVDR 2017/746 and various MDCG guidance documents.Full awareness of the applicable European and Harmonized Standards for the control and regulation of IVD.Familiar with FDA 510K and PMA processes and been involved in a clinical trial FDA pre submission and 510K preparation.Support Global markets with their regulatory submissions and respond to deficiency letters in coordination with internal Subject Mater Experts (SMEs) to generate and provide these markets with the necessary documents.Maintain regulatory databases for assigned devices on RA Shared drive and RA Sharepoint.Develop innovative and sustainable medical device regulatory strategies.Represent RA, review and/or approve design control deliverables and Design History File (DHF)Provide international regulatory impact assessments for proposed product changes and help closure of Change Control Requests in timely manner.Work closely with cross functional and project teams to ensure regulatory risks are identified, communicated, and properly addressed.Contribute to internal regulatory processes and procedures for all our test strips, general purpose reagents and consumables.Curallux LLC. FloridaRegulatory Affairs Consultant (February 2020 to Feb.2021)Managing and coordinating the clinical study program for the companys laser medical devices.Self-Employed, Ann Arbor, MichiganUSANA Health Sciences Business Associate, (September 2016 to January 2020)Sales and Marketing of multivitamins, nutritional and dietary supplements and healthcare products, topical creams and ointments.Amdipharm Mercury (AMCo), Dublin, IrelandArea Manager, Middle East and Gulf Markets, (September 2013 to April 2015)Responsible for all products life cycle management activities in Middle East and Gulf markets with budget sales of GBP 6 7 Million.Provided regulatory direction on regional regulatory mechanisms to optimize products performance and achieve sales targets in the area.Participated in the development and execution of regional regulatory product strategies and contingency planning to ensure continuous product supply to the markets and avoid any Out of Stock (OOS) situation.Implemented and managed a number of Distributors Agreements (DAs) and amendments to existing agreements. Negotiated all the commercial, regulatory, financial, sales and promotion terms and conditions with our business partners.Developed and maintained constructive relations with key internal and external stake holders, e.g. Cross-functional teams, Business Partners/Agents, and Health Authorities.Involved in all regulatory and commercial activities such as due diligence and countries road shows following product(s) acquisition to monitor product performance and competitors activities. It also included the collection of regulatory intelligence/information, sales data (private, government and tenders), pricing information and packaging/labeling text material which facilitates a smooth Marketing Authorizations (MA) transfer of the divested product(s) in these markets.Dr. Reddys Laboratories (UK), Ltd. Yorkshire, UKRegulatory Affairs Consultant, EU Markets, (December 2012 to April 2013)Coordinated dossier preparation and reviewed regulatory submissions (DCP and National) within defined timelines and in accordance with established standards.Acted as the contact point within the company for the concerned products/projects.Collaborated with all relevant functions within the company to obtain and maintain Marketing Authorizations (MAs) approval. Provided regulatory advice and input to the companys Change Control procedure, and supported the regulatory compliance teams.Attended relevant meetings to provide regulatory input to project teams.Approved product labelling and packaging artwork material.Zimmer GmbH, SwitzerlandInternational Regulatory Affairs Consultant, Europe Middle East Africa (EMEA)Markets, (February 2012 to June 2012)Developed regulatory strategies and plans for the preparation and submission of new medical devices (Class II III).Reviewed all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness and compliance with local regulatory standards including ISO, EC Quality, and Declaration Of Conformity (DoC) certificates as well as FDA Certificates for Foreign Gov. (CFGs) and Free Sale Certificates (FSCs)Managed the final product submissions and negotiated effectively with local distributors/regulatory authorities to obtain timely product approvals.Built excellent working relationship with US regulatory counterparts at Global HQ to facilitate the registration of US manufactured and marketed devices in EMEA markets.Amdipharm Plc. UK and Amdipharm Ltd. IrelandInternational Regulatory Affairs Manager, (September 2007 June 2011)Provided regulatory and registration support of Amdipharm products in International/Emerging markets including: Middle East, Gulf states, Africa, Australia & New Zealand, Canada and Asia PAC.Provided regulatory guidance to multidisciplinary teams to ensure that Marketing Authorizations (MAs) and life cycle management activities in the International territories were performed in time and in compliance with applicable regulatory legislations and guidelines.Compiled and submitted MAs, Variation applications, License renewals and CMC data and responses to Health Authorities in a timely manner and in coordination with colleagues and third parties to ensure that all required inputs are available.Built and maintained successful working relationships with affiliates and Health Authorities in the International territories.Grew the company business and explored new potential markets for MA transfers.Appointed affiliates/agents in new territories to be the point of contact and liaised with their corresponding Health Authorities to facilitate MA applications and all other regulatory issues.Reviewed, annotated and approved artwork components for MA transfers, variations, SPC updates.Co-ordinated and executed regulatory projects in the International territories according to agreed timelines in conjunction with internal departments and third party organizations.Contributed to development and implementation of departmental procedures, policies and systems.Reviewed all relevant data and documents from Technical and Quality departments such as CMC and Quality Overall Summary sections of the CTD for eligibility and compliance with the local regulations.Worked closely with the Medical Director to implement new safety updates to Summary of Product Characteristics (SPCs) and Package Inserts (PIs) of products. Ensured all safety issues received from markets are rapidly communicated to Medical Information and Pharmacovigilance team.Worked closely with the QA/QP to resolve product quality issues received from the markets.Managed the Irish operation since its establishment in Mid 2009 comprising of regulatory affairs, Pharmacovigilance and admin/finance functions.More than 200 MA application transfers were approved and 180 renewals and license variations were submitted and approved in the Intl markets. I also managed to register the company in Saudi Arabia, UAE and the rest of the GCC countries and established a solid infrastructure of local distributors and regulatory affairs consultants in the region.Michigan, USA. Voluntary work for charity, (Apr. 2004 Sept. 2006)Pharmaceutical Consultant - Dublin Ireland, (Oct.2001 Apr.2004)Provided consultancy services to small pharmaceutical firms. This included development of marketing plans, market research projects and promotional campaigns for already marketed products and developing pre launch, launch and post launch plans and strategies for other products in the pipeline.Merck Sharp & Dohme Dubai, UAERegional Product Manager Gulf Area, (Aug.2000 August 2001)Developed, implemented and monitored different marketing programs to achieve the designated sales objectives. One year after launching a breakthrough product for arthritis in 4 Gulf states, its ranking steadily moved up from 5th position to a market leader in its therapeutic class, and its market share jumped from an average of 7% to more than 30% in one country and 18% in another according to IMS.Provided continuous medical education of key opinion leaders to ensure their support and advocacy.Developed plans to counteract competitor activity and messaging.Continuous training of medical reps. to ensure effective delivery of marketing and promotional messages and handling concerns.Conducted field visits with the sales force throughout the Gulf countries, arranged, moderated, and conducted product presentations in hospital meetings, round table discussions and dinner debates.Represented Gulf area as part of the regional marketing team meetings to share successful initiatives and co- ordinate marketing activities.Arranged speaker tours and scientific programs in different Gulf countriesMedical/Regulatory Affairs Manager (Dec.1999 Aug.2000)Provided medical/scientific support as part of the marketing efforts to grow the strategic products in accordance with their marketing and promotional strategies.Ensured maintaining a high standard of medical and product knowledge within the sales force by:oDeveloping and conducting training courses for new products, new campaigns and landmark clinical trials.oEscorting the medical reps. in their field visits to ensure establishment and proper delivery of new medical concepts and marketing messages to the target doctors and key opinion leaders. Maintaining close relationship with all key opinion leaders in the Gulf through continuous medical education (CME) programs to ensure their early involvement, advocacy and support for published product clinical data and press releases.Conducting, supporting and participating in evening meetings, presentations and round table discussions for a wide variety of products in the UAE .Assigned as Country Regulatory Liaison (CRL) by the regional office in France to manage all regulatory requirements and products registration in the UAE. Acted as the companys point of contact with the local agent/distributor in the country.Astra Middle East (Saudi Arabia)Medical/Regulatory Affairs Manager (Sept.1994 Jul. 1997)Responsible for overall of registration and regulatory affairs in Saudi Arabia including the review of the Standard European Registration file followed by timely preparation and submission of high-quality regulatory documentation to fulfill the Health Authorities requirements, and following the process throughout the different phases of registration.Negotiated with health officials in the Kingdom.Worked closely with our local agent/distributor to manage all regulatory and commercial activities in the country and help solve any problems related to designated products.Provided medical support to the marketing and sales personnel throughout the region. Trained the sales force for new promotional campaigns.Bristol-Myers Squibb, Saudi ArabiaClinical Research Coordinator/Associate, (Nov. 1991Jul 1994)Initiated, monitored and coordinated phase IV multicenter clinical trials as well as In-Vitro studies throughout a number of institutional (university and military) hospitals in Saudi Arabia.Selected research investigators and trial sites, arranged investigators meetings and study briefing. Conducted frequent site visits to ensure patient recruitment was on track, inclusion and exclusion criteria were met, checked and validated data, collected completed CRFs within the allocated timeframe.Completed and sent adverse drug reactions reports in accordance with the companys pharmacovigilance guidelines to the regional medical departmentPromoted the full range of the companys Oncology products.Eastman Kodak, Cairo, EgyptDiagnostic Medical Representative, (Aug. 89 Sept.91)Promoted dry chemistry blood analyzers, all types of diagnostic imaging films, X-ray processors, and other diagnostic kits throughout Egypt.Established good working relationships with top opinion leaders (Pathologists & hematologists) in the market.Resident doctor, Ministry of Health Hospitals, Egypt (1986 1989)EDUCATIONMBA Michael Smurfit Graduate School of Business, University College Dublin, Ireland.Full time 1997/1998 (Honours). Dissertation Title: Evaluation of Different Product/Line Extension Strategies in the Pharmaceutical IndustryM.Sc. Tropical Medicine, Ain Shams University, Cairo (1990)M.B.B.Ch. Faculty of Medicine, Ain Shams University, Cairo (1983)ADDITIONAL TRAINING AND EXPERIENCELeadership Programme, By Ashtead Performance Group Essex, UK (April 2009)Pharmaceutical Marketing Excellence, By Mcnally and Associates Ireland (Feb.2002)Media Skills Training course, By Interscience Co. Nicosia, Cyprus (May, 2000)New Manager Orientation Course, By Strmberg Consulting, Nicosia - Cyprus (Feb.2000)Astra Basic Course in Clinical Trials Sdertuna Castle, Sweden (March, 1995)Time Management, By Eastman Kodak Co. New York, USA (Oct Nov. 1989) |
