» Manager - Regulatory Affairs: B.Sc Latest Jobs Openings in Companies in India
Name: Syed Moinuddin Quadri
Objective : To be associated with a growing organization and make a positive contribution through my hard work, dedication, vast technical experience and professional skills and strive continuously for updating professional excellence and individual satisfaction.
Qualification :
B.Sc. (Computer Science, Statistics & Mathematics) 1993 67% Gulbarga University, Gulbarga.
Job Profile :
I. Currently working as “Manager - Regulatory Affairs” in Global Pharmatech Pvt.Ltd., Hosur, a world class pharmaceutical company manufacturing liquid injectables for pharmaceutical giants like GSK, Pfizer, Cipla, Dr. Reddy’s, etc. Here my responsibilities are;
• Ensuring GMP/GLP and Regulatory compliance in the systems and procedures of manufacturing, quality control analysis and packaging of finished products.
• Preparing, reviewing and updating dossiers for the registration of products in different countries namely Russia, Sri Lanka, Australia, Canada, Brazil, Chile, Algeria, Myanmar, etc.
• Completing registration formalities for registering the firm and drug products in the aforesaid countries.
• Interacting with different Regulatory Agencies on different regulatory issues and attending to the queries from time to time.
II. 3 Years experience as “Group Leader – Clinical Documentation” in Lotus Labs Pvt. Ltd., a Contract Research Organization, engaged in Clinical Trials. My responsibilities include;
• Ensuring ICH-GCP and Regulatory compliance in all the procedures of clinical trials and subsequent documentation.
• Preparing and reviewing Protocols, Clinical Study Reports, Informed Consent Forms (ICFs) and Case Report Forms (CRFs) for clinical trials. Review of documents for completeness, grammar, accuracy and consistency in compliance with ICH-GCP guidelines and Regulatory requirements. Updating the management about the status of reports on weekly basis.
• Developing and implementing processes to improve data management efficiency and maintaining departmental Standard Operating Procedures, policies and work guidelines.
• Preparing, reviewing and revising templates (formats) for Protocols, Clinical Study Reports, ICFs, CRFs, etc. in compliance with GCP guidelines and Regulatory requirements.
• Providing induction training for newly joined staff, literature search as and when required, preparing and revising SOPs and conducting weekly SOP training classes for all clinical staff.
• Training, assisting and supervising documentation staff ; overall supervision of documentation activities.
III. Three years experience as “Regulatory Affairs Officer” in Medreich Sterilab Ltd., a professionally managed pharmaceutical company manufacturing formulations (antibiotics). Here my responsibilities are;
• Preparing, reviewing and updating dossiers for the registration of drug products in different countries namely USA, UK, South Africa, Australia, Canada, Brazil, etc.
• Ensuring regulatory compliance in all the processes and products. Preparation of common technical documents.
• Facing audits by International Regulatory Agencies like US-FDA, MCC-South Africa, ANVISA Brazil and ensuring implementation of subsequent corrective action plans.
• Data compilation and preparation of Site Master Files, SOPs, etc. in compliance with regulatory guidelines.
• Interacting with different Regulatory Agencies on different regulatory issues and attending to the queries from time to time.
• Training, assisting and supervising regulatory staff.
IV. Four years experience as “Documentation Officer” in R&D Center, Natural Remedies Pvt. Ltd., A 100% export oriented herbal products company in Bangalore. Here I was responsible for;
• Research and clinical data management in compliance with Standard Operating Procedures (SOPs), Regulatory requirements and ICH-GCP guidelines. Review of documents for completeness, grammar, accuracy and consistency.
• Developing, Co-ordinating and monitoring the data management process across the data management team, developing and maintaining documentation and data management guidelines and auditing reports and files for discrepancies.
• Preparing, updating & editing master documents (Herbal extracts), dossiers (Human & Veterinary products), Clinical Trial Reports, Case Report Forms, product profiles & catalogues.
• Preparing molecular structures of different phytochemicals (using ISIS Draw, ChemSkech and Chemwind softwares), different types of graphs for Clinical Trial Reports (using MS-Excel) and process flow charts for different extraction procedures.
VI. 1 ½ Year’s Experience as Center Manager at B.D.P.S LTD., Computer Institute, Bidar. Here I was totally responsible for overall administration and maintenance of the center including business development and profit making.
Skills :
• Having excellent verbal & written communication skills, organizational skills, problem solving skills, team oriented and committed to a strong work ethic.
• Good interpersonal skills; ability to interact with multidisciplinary groups.
• Working independently with minimal supervision.
• Detail & deadline oriented; well organized.
Computer Proficiency :
MS-Office, Page Maker, Corel Draw, Photoshop, Adobe Acrobat, ISIS Draw, ChemSketch, Chemwind, MS-DOS, WINDOWS 95/98, COBOL, ORACLE 8.0.
Personal Information :
Date of birth : 15.12.1970.
Nationality : Indian.
Marital status : Married.
Languages : English, Hindi, Kannada
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