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<pre>Array ( [var] => cut_url ) </pre> Resume for Amna S. for Pharmacist / Healthcare & Social Assistance in Karachi, Pakistan. Search More Resumes for Pharmacist on Resumark.com #BRFWV8VBP
 

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Resume for Amna S. for Pharmacist / Healthcare & Social Assistance in Karachi, Pakistan




Occupation: Pharmacist Industry: Healthcare & Social Assistance
Country: Pakistan City: Karachi
State: Sindh ZIP: 74900



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Amna S. | |
|Professional R‰sum‰ |
|Date of | June | |
|Birth: | | |
|Address: |Pakistan |
|Contact: | |Pak no.: + |
|Emails: | |
|Professional|Assistant Manager Regulatory Affairs with a track record of |
|Summary |years successes in the industry of Pharmaceutical “Regulatory |
| |Affairs" in leading project and product teams by creating tools |
| |and processes for developing and marketed products to drive |
| |business growth by product registration as per CTD format with |
| |vast knowledge of Drug Regulatory and Pharmacy Law, hardship |
| |cases, cross functional activities with knowledge of Quality |
| |assurance, Quality Control, Production, Medical and marketing |
| |team as a team player. With theoretical knowledge of the FDA |
| |procedures actively involved in Global Labeling and update of |
| |products as member of labeling team and also actively involved in|
| |Due diligence team. Key strengths include passion with highly |
| |motivating interpersonal, analytical and problem solving skills, |
| |commitment to attain business results, and people development |
| |with a focus to exceed expectations. Continually demonstrate |
| |strategic ability and provide strong leadership capabilities with|
| |a multi tasking with additional ability to learn fast and master |
| |product complex. Lead teams in direct interactions with |
| |MOHPakistan. |
| |International Product Registration experiences provide a global |
| |perspective and the practical experience required to support |
| |individuals and the organization to reach their highest |
| |potential. |
[pic]
Professional Career Summary:
|Professional Degree : |Pharmacy Registered with Pakistan Pharmacy Council |
|Education : |MBA Marketing; B.Pharmacy, D Pharm certification inprocess,|
| |Clinical Research Associate in process |
|Total Work Experience : |Duration | |
|Feb – to date | |
[pic]
Work Experience
|CURRENT ORGANIZATION |
|Sanofiaventis Pakistan limited |
|Organization Type : |Pharmaceutical Manufacturers & Pharmaceutical Exporters |
|Designation : |Assistant Manager Regulatory Affairs |
|Tenure : |Sep to date |
|Location : |Pakistan, Karachi |
|Areas of Experience|Drugs Regulatory Affairs, Business development, Quality Control & |
|: |Production |
|Reporting to : |Director Regulatory Affairs |
|Responsibility : |Management Reporting, Product Registration submission and approval, |
| |Hardship and pricing cases, counterfeit cases, Product complaints, |
| |Drug labeling issues and updates, Formulating strategy for submission |
| |till launch, Leading & Supervision of team, looking after the entire |
| |Regulatory activities by assisting head of Drugs regulatory affairs |
| |and liaison with Ministry of health – Pakistan. |
|Brief Job Description|Preparing and supervising in registration application Pakistan and |
|: |follow up of registration status for local / generic products, |
| |Imported products and vaccines |
| |Being a member of New product / drug development team: |
| |Actively involved in the Product development of the new products to |
| |ensure the quality before and after submission |
| |Involved in the review, evaluation of the stability studies |
| |protocols, chromatograph and results and submission to MOH –Pakistan|
| | |
| |Liaise with Medical affairs / researchers of Pakistan and global for |
| |the clinical studies or investigations, safety and therapeutic studies|
| | |
| |Preparation of registration of Product renewal of local , imported and|
| |vaccines business |
| |Preparation/Review and submission of product registration dossier as |
| |per budget wish list of the following countries: |
| |Malaysia |
| |Thailand |
| |Involved actively in the project of Counterfeit issues in Pakistan in |
| |collaboration with marketing department and supply chain |
| |Member of Cross Functional Team for the development of the product |
| |till Launch activities. |
| |Take up the issues for prompt identification and immediate |
| |communication of potential alert reports and safety signals to Health |
| |authorities in cooperation with medical affairs |
| |Involved in application of hardship cases and price increase for the |
| |registered products with the help of industrial financial controller |
| |and business development |
| |Initiate the preparation of Standard operating procedures as per |
| |guidelines for the registration of products and pricing |
| |Supervising and preparation of product artwork and labeling |
| |information leaflet reviewing proposed Labeling changes / variation |
| |and updates as per International guidelines or company core data sheet|
| |and finalizing in cooperation with marketing, medical affairs |
| |Responsible for marketing activities in Product Promotional material, |
| |medical issues and change alerts and also assists Regulatory head in |
| |development of the launch calendar for the new products planning. |
| |Providing regulatory support to the head of DRA to maintain regulatory|
| |compliance for marketed products and assist in Formulating regulatory |
| |strategies and Archiving of regulatory support documents via launching|
| |Regulatory server access |
| |Corresponds with MOH for the assigned projects / products by assisting|
| |DRA supervisor and keep supervisor updated on status and involve |
| |participation of others when appropriate |
| |Archiving information about patent status in Pakistan |
| |Periodic update safety report PSUR for regional reporting |
| |Supervising in reporting Product Technical complains PTC with the |
| |help of supply chain activities and distribution |
| |Monthly status reporting for regional head office – France |
| |Assist DRA head for the monthly reporting of the projects and |
| |achievement of DRA to General Manager |
|Achievements |Performance recognition award honored in the year . |
|: |Successful product price increase through assisting DRA head |
| |Implementation and preparation of Standard operating procedures |
| |Launch and implementation of regulatory server |
| |Successful registration of products |
| |Change of status of products |
| |Meeting with MOH personals Islamabad on related issues with ideas |
| |and with the clear and broad supervision of DRA Head |
| |Assist in successful change in artwork of products to maintain and |
| |gain profits by supervising regulatory technical support subordinate |
| |and plant logistics |
| |Involved in successful training of inter

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