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INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRSINDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS(12 MONTHS DISTANCE PARTICIPATION PROGRAM)(12 MONTHS DISTANCE PARTICIPATION PROGRAM)
BATCH- VIIthBATCH- VIIth Offered by: Bioinformatics Institute Of IndiaOffered by: Bioinformatics Institute Of India
WHAT IS PHARMA REGULATORY AFFAIRS (DISTANCE WHAT IS PHARMA REGULATORY AFFAIRS (DISTANCE LEARNING PROGRAM) ALL ABOUT ?LEARNING PROGRAM) ALL ABOUT ?
This This Distance learning programDistance learning program is intended to provide is intended to provide students with a basic understanding of the areas of regulatory students with a basic understanding of the areas of regulatory affairs and quality operations. Students will be prepared for affairs and quality operations. Students will be prepared for occupations involving drug or medical device submissions and occupations involving drug or medical device submissions and quality assurance functions and roles.quality assurance functions and roles.
The The Distance Learning ProgramDistance Learning Program will provide the student with will provide the student with the fundamentals required in both regulatory affairs and quality the fundamentals required in both regulatory affairs and quality operations.. Experience gained will allow the student to be operations.. Experience gained will allow the student to be exposed to one of the many employment possibilities attainable exposed to one of the many employment possibilities attainable upon graduationupon graduation..
The The Distance Learning ProgramDistance Learning Program further provides more further provides more detailed and specific exposure to the areas of regulatory affairs detailed and specific exposure to the areas of regulatory affairs and quality operationand quality operation
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
HOW DOES REGULATORY AFFAIRS HOW DOES REGULATORY AFFAIRS CERTIFICATION CERTIFICATION ENHANCES SOMEONE’S EMPLOYMENT ENHANCES SOMEONE’S EMPLOYMENT PROSPECTS?PROSPECTS?
““Certified professionals "earn anywhere from 20 to Certified professionals "earn anywhere from 20 to 30% 30% more than their peers. In addition, many companies—more than their peers. In addition, many companies—bothbothlarge and small to midsize--are now beginning to large and small to midsize--are now beginning to indicate indicate that REGULATORY AFFAIRS CERTIFICATION is a that REGULATORY AFFAIRS CERTIFICATION is a desirable desirable qualification."qualification."
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
CAREERS IN PHARMA REGULATORY AFFAIRS ?CAREERS IN PHARMA REGULATORY AFFAIRS ?
Graduates from this Distance Learning program may pursue Graduates from this Distance Learning program may pursue careers in the areas of Regulatory Affairs and Quality Operations. careers in the areas of Regulatory Affairs and Quality Operations. Career options include the pharmaceutical, biotechnological, Career options include the pharmaceutical, biotechnological, veterinary, cosmetic and food industries.veterinary, cosmetic and food industries.
Graduates will find employment asGraduates will find employment as
Regulatory Affairs AssociatesRegulatory Affairs AssociatesRegulatory Affairs AssistantsRegulatory Affairs AssistantsQuality Assurance AssociatesQuality Assurance AssociatesQuality Assurance InvestigatorsQuality Assurance InvestigatorsDocumentation Administrators andDocumentation Administrators andMedical Information AssociatesMedical Information AssociatesIn Contract Research Organization(CRO) Pharma regulatory In Contract Research Organization(CRO) Pharma regulatory affairs professionals are responsible for maintaining records of affairs professionals are responsible for maintaining records of Common Technical Documents for Pharmaceutical Dossiers.Common Technical Documents for Pharmaceutical Dossiers.
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
HOW MEAN BASE SALARY OF A PHARMA REGULATORY HOW MEAN BASE SALARY OF A PHARMA REGULATORY AFFAIRS PROFESSIONAL DIFFER BY EMPLOYER TYPE ?AFFAIRS PROFESSIONAL DIFFER BY EMPLOYER TYPE ?
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
SOURCE: Regulatory Affairs Professional Society
JOBS OPPORTUNITIES AND ROLES FOR PHARMA JOBS OPPORTUNITIES AND ROLES FOR PHARMA REGULATORY AFFAIRS PROFESSIONALS ?REGULATORY AFFAIRS PROFESSIONALS ?
Regulatory affairs jobs play an important role in the Regulatory affairs jobs play an important role in the pharmaceutical industry.The pharmaceutical industry has built up pharmaceutical industry.The pharmaceutical industry has built up rigorous processes for the licensing and compliance of the drugs rigorous processes for the licensing and compliance of the drugs it uses. Hence Regulatory affairs jobs within pharmaceuticals it uses. Hence Regulatory affairs jobs within pharmaceuticals centres around coordinating and managing licensing processes centres around coordinating and managing licensing processes for everything from the approval of new Medicines, chemicals, for everything from the approval of new Medicines, chemicals, medical devices and other products used in pharmaceuticals and medical devices and other products used in pharmaceuticals and healthcare.Once established in regulatory affairs jobs there is are healthcare.Once established in regulatory affairs jobs there is are good career structures available which can be pursued within good career structures available which can be pursued within companies, and in addition the pharmaceutical industry is a large companies, and in addition the pharmaceutical industry is a large pond within which careers can be pursued cross company if pond within which careers can be pursued cross company if necessarynecessary..
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
COURSEWARE OFFERED BY BII COURSEWARE OFFERED BY BII
BOOKSBOOKS
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
MULTIMEDIA CDs
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
PROGRAM METHODOLOGYPROGRAM METHODOLOGY
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
REPRESENTATIVE LIST OF OUR CURRENT AND FORMERREPRESENTATIVE LIST OF OUR CURRENT AND FORMERSTUDENTS WHO ARE SUCCESFULLY PLACED AND STUDENTS WHO ARE SUCCESFULLY PLACED AND PRESENTLY WORKING WITH THE LEADING NAMES IN PRESENTLY WORKING WITH THE LEADING NAMES IN THE PHARMACEUTICAL INDUSTRYTHE PHARMACEUTICAL INDUSTRY
. . REPRESENTATIVE LIST OF OUR CURRENT AND FORMERREPRESENTATIVE LIST OF OUR CURRENT AND FORMERPHARMA REGULATORY AFFAIRS PROGRAM STUDENTS WHOPHARMA REGULATORY AFFAIRS PROGRAM STUDENTS WHOARE SUCCESFULLY PLACED AND CURRENTLY WORKING WITH ARE SUCCESFULLY PLACED AND CURRENTLY WORKING WITH THE LEADING NAMESTHE LEADING NAMES
S.noS.no NameName CompanyCompany Designation and Designation and DepartmentDepartment
11 Alpa Sameer GandhiAlpa Sameer Gandhi Techno DrugsTechno Drugs
Regulatory AffairsRegulatory Affairs
22 Shilpa Arun PitaleShilpa Arun Pitale Erica Pharma Pvt. Ltd. Erica Pharma Pvt. Ltd. GM - egulatory AffairsGM - egulatory Affairs
33 Visalia Abhijit MaliVisalia Abhijit Mali Calix Chemicals & Calix Chemicals & Pharmaceuticals Pvt.Ltd.Pharmaceuticals Pvt.Ltd.
Regulatory OfficerRegulatory Officer
4 4 Viren DokeViren Doke Associated Capsules Pvt.Ltd.Associated Capsules Pvt.Ltd. Manager- Regulatory Manager- Regulatory AffairsAffairs
55 Pankaj BhattPankaj Bhatt Pavucoa Biotech Ltd.Pavucoa Biotech Ltd. Executive-Regulatory Executive-Regulatory AffairsAffairs
66 Bharathi B.K. BurliBharathi B.K. Burli Bal Pharma Ltd.Bal Pharma Ltd. Regulatory Affairs -Regulatory Affairs -ExecutiveExecutive
77 Dipeeka SatveDipeeka Satve Ipca Labs. Ltd.Ipca Labs. Ltd. Regulatory AffairsRegulatory Affairs
88 Abhay KenjaleAbhay Kenjale IPCA Laboratories Ltd.IPCA Laboratories Ltd. Sr.Officer Reg. AffairsSr.Officer Reg. Affairs
99 Lily D'SouzaLily D'Souza IPCA Laboratories Ltd.IPCA Laboratories Ltd. Regulatory OfficerRegulatory Officer
1010
Sangita PoddarSangita Poddar .. Micro Labs Ltd.Micro Labs Ltd. - - Regulatory Affairs Regulatory Affairs
ExecutiveExecutiveINDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
1111 Mrs.Mrs. MrunalMrunal Sameer Sameer GokhaleGokhale
Ajanta Pharma Ltd.Ajanta Pharma Ltd. Officer-Drug regulatory Officer-Drug regulatory AffairsAffairs
1212 Anita MuraliAnita Murali Johnson & JohnsonLtd.Johnson & JohnsonLtd. Trainee Regulatory AffairsTrainee Regulatory AffairsAjanta Ajanta
Pharma Ltd.Pharma Ltd.
1313 Sowmya Shree R.Sowmya Shree R. Medreich Ltd.Medreich Ltd. Regulatories AffairsRegulatories Affairs
1414 Manjunath R.Manjunath R. Medreich Ltd.Medreich Ltd. Supervisor Regulatory Supervisor Regulatory AffairsAffairs
1515 Akhlas AhmedAkhlas Ahmed IPCA Laboratories Ltd.IPCA Laboratories Ltd. Executive Regulatory affairs Executive Regulatory affairs
1616 N. SridharN. Sridhar Medreich Ltd.Medreich Ltd. Officer- Regulatory AffairsOfficer- Regulatory Affairs
1717 ChristanciaChristancia Celina Celina D'SouzaD'Souza
Aristo Pharma Aristo Pharma Executive Regulatory affairs Executive Regulatory affairs
1818 Mangesh Karbhari SahaneMangesh Karbhari Sahane Cipla Ltd.Cipla Ltd. Executive Regulatory affairs Executive Regulatory affairs
1919 Sweat Shaker BaingSweat Shaker Baing Cipla LtdCipla Ltd Regulatory OfficerRegulatory Officer
2020 Arun Digamber KulkarniArun Digamber Kulkarni Fresenius Kabi India Pvt. Ltd.Fresenius Kabi India Pvt. Ltd. Manager Compliance & Manager Compliance & RegulatoryRegulatory
2121 Garcia V.Garcia V. Micro LabsMicro Labs Executive - Regulatory Executive - Regulatory AffairsAffairs
2222 Visalia Premed ChaudharyVisalia Premed Chaudhary Indoco Remedies Ltd.Indoco Remedies Ltd. Executive -Reg.AffairsExecutive -Reg.Affairs
2323 Shaker Gopala KrishnaShaker Gopala Krishna Medriech Sterilab Ltd.Medriech Sterilab Ltd. Executive Regulatory affairsExecutive Regulatory affairs
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
2424 Rashmi DankerRashmi Danker SRS PharmaSRS Pharma Regulatory Affairs-OfficerRegulatory Affairs-Officer
2525 Sneak Susan Sneak Susan AbrahamAbraham
Galaxosmithk LineGalaxosmithk Line Regulatory Affairs-OfficerRegulatory Affairs-Officer
2626 Jingoish Rohit Jingoish Rohit kumarkumar
Marck Biosciences Ltd.Marck Biosciences Ltd. Officer-Regulatory AffairsOfficer-Regulatory Affairs
2727 Venkata Rajesh Venkata Rajesh DasyapuDasyapu
Glochem Industries Glochem Industries Ltd.Ltd.
Officer- Regulatory AffairsOfficer- Regulatory Affairs
2828 Sachin RawalSachin Rawal Forum ProductsForum Products Regulatory ManagerRegulatory Manager
2929 Adam Govardhan Adam Govardhan ShrinivasShrinivas
Yamsi Lab Ltd Solapur Yamsi Lab Ltd Solapur Midc Area Midc Area
Regulatory WorkRegulatory Work
3030 Deepali Ashish Deepali Ashish KulkarniKulkarni
Cipla Ltd.Cipla Ltd. Reg.OfficerReg.Officer
3131 Sujata Suresh DaliSujata Suresh Dali Wockhardt Ltd.Wockhardt Ltd. Trainee in Regulatory AffairsTrainee in Regulatory Affairs
3232 Anitha K.N.Anitha K.N. Strides Arcolab LtdStrides Arcolab Ltd Regulatory affairs-ExecutiveRegulatory affairs-Executive
3333 SandeepSinghSandeepSingh Alembic Ltd.Alembic Ltd. Chemist Reg.AffairsChemist Reg.Affairs
3434 HardayalSinghHardayalSinghDhanjalDhanjal
Phlox Pharma LtdPhlox Pharma Ltd Chemist Reg.AffairsChemist Reg.Affairs
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
35 Shamsundar Pradiprao Nalawade
Elder Projects. Apprentice Trainee-Regulatory Affairs
36 S.R. Obliraj Medopharm Trainee –Regulatory Affairs
37 Seettha Ganeshan TTK Pharma Ltd. Regulatory Head
38 UmajiBhalchandra
Redkar Pharma Base India
Manager-Regulatory Affairs
39 Pradnya VasantPrabhudesai
Aventis Pharma Ltd. Trainee-Regulatory Affairs
40 Merilin Lobo Glenmark Research centre
Associate-Regulaory Affairs
41 Amrita SunilMukherjee
Cosme Health Care Executive-Regulatory Affairs
42 Ruchi Jain Jubiliant Organosys, Noida
Associate-Regulatory Affairs
43 Jasbinder Singh Orchid Chem & Pharma
Manager-Regulatory Affairs
44 M. Reeta Inno Pharm Pvt Ltd. Executive-Regulatory Affairs
45 Sukh Nandan Singh Themis Medicare Ltd.
Manager-Regulatory Affairs
46 Geetha Priya Goldstein Laboratories, Chennai
Trainee-Regulatory Affairs
47 Ramesh Pennama Reddy Sales Worth India Ltd.
Tech. Executive-Regulatory Affairs
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
INDUSTRY PROGRAM IN PHARMA REGUALTORY AFFAIRS
48 Shraddha Srivastava Axis Diagnostics & Biotech Ltd.
Asst.-Regulatory Affairs
49 Roopa Shiv KumarBansal
Lupin Ltd. Tr.Officer-Regulatory Affairs
50 Sanjeev Mahajan Ranbaxy Laboratory Ltd.
Officer-Regualtory Affairs
51 Gosika Narendra Suven Life Sciences Ltd
Officer-Regulatory Affairs
52 Mohammed Shakeel S.
Strides Arcolab Executive-Regulatory Affairs
53 Aruna S. Srushti Pharma Trainee-Regulatory Affairs
54 N.M. Vijaya Lakshmi Indian Immuno Logicals Ltd.
Officer -Regulatory Affairs
55 Anil Kumar Wallace Pharma, Goa Head –Regulatory Affairs
56 Sumit Nagpal Mankind Pharma Ltd. Delhi
Sr.Executive-Regulatory Affairs
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
57 Harjit Singh Ranbaxy Lab.Ltd Executive-Regulatory Affairs
58 Nidhi Jain Deccan Neutra Ceutical Pvt.Ltd.
Executive-Reglaory Affairs
59 Swanand S. Kelkar Samar Gadam
Nicholas Piramal Ltd.Cipla , Goa
Sr.Executive-Regulatory Affairs
60 Rashmi Dawar Vestergaaxd Erandson Trainee-Regulatory Affairs
61 Sunil Pal Wockhardt Ltd. Manager-Regulatory Affairs
62 Sujata Tukaram walke Maneesh Pharma. Pvt.Ltd. Mumbai
Officer-Regulatory Affairs
63 Sharada Bhaskar Mayekar
Plethico Pharmaceuticals
Executives-Regulatory Affairs
64 Susheel Agarwal Ranbaxy Research Lab Regulatory Affairs
65 Meenal Yeole Meyer Organics Pvt.Ltd.
Apprentice-Regulatory Affairs
66 Sudhir Kumar Sharma Subriya Pharmaceuticals Ltd.
Trainee-Regulatory Affairs
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
67 Premjith Balakrishnan Merind Ltd, India Sr.Executive-Regulatory Affairs
68 Siddhartha Roy Alpha Beta Pvt.Ltd. Trainee-Regulatory Affairs
69 Dilip Kumar Saralaya Banglore Pharmaceuticals & Research Ltd.
Sr.Regulatory Officer
70 Rashmi Pillay German Remedies Ltd. Junior Regulatory Officer
71 Arun Kumar Morepen Labs ltd. Regulatory Head
7272 Shital Kumar Takale Elder Pharmaceuticals Executive-Regulatory Affairs
73 Vijay Sah Sarita Chaudhary Cipla Ltd. Trainee-Regulatory Affairs
74 N. Rajan Dr.Reddy,s Laboratory Senior Executive Regulatory Affairs
75 Ulligadla Anjan Kumar M/s.Bioserve Chemical Research Pvt.Ltd.
Sr.Executives-Regulatory Affairs
76 Balchandra Ghare Emcure Pharma Regulatory Officer
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
77 Sachin Shiral Dr. Reddy,s Lab Sr Executive Regulatory Affairs
78 Sree Lakshmi Konakanchi Meyer Health Care Pvt.Ltd., Banglore
Head –Regulatory Affairs
79 Girija Shankar Tiwari Windlas Biotech Ltd. Sr.Officer-Regulatory
80 Rajni Chaudhary Ind.Swift Laboratories Ltd.
Sr.Officer-Regulatory
81 Pradeep Srivastava Ranbaxy Trianee-Regulatory Affairs
82 Indrajit Bhosle Patil Strides Arcolab Executive Regulaory Affairs
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
83 Gosika Narendra Suven Life Sciences Ltd.
Regulaory Officer
84 Aruna S. Srushti Pharma
Regulaory Head
85 N.M. Vijaya Lakshmi
Indian Immuno Logicals Ltd.
Officer-Regulatory
86 Swanand S.Kelkar
Nicholas Piramal.
Executives – Regulatory Affairs
87 Sunil Pal Wockhard Sr.Executive –Regulatory Affairs
88 Ravi Kumar
Uddanti
Virchow Biotech Pvt.Ltd.
Executive-Regulatory Affairs
89 K. Jegadheesh Balaji
Proventus Life Sciences Pvt.Ltd.
GM – Regulatory Operation
90 AnupamaMoorthigari
Aurobindo pharma Ltd.
Regulatory Department
91 Amit Bhardwaj Glenmark Pharma Ltd.
Manager-Regulatory Affairs
95 Rafik Patil Glaxo Smithkline Pvt. Ltd.
Head-Regulatory Affairs
96 Pothineni Prashanthi Aurobindo Pharma Ltd. Officer-Regulatory Affairs
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
92 Jayant Khuspe Sandoz Pvt. Ltd. Head-Regulatory Affairs
93 Nitin Patil Sandoz Pvt. Ltd. Officer-Regulatory Affairs
94 Devleena Sengupta Lupin Ltd. Trainee-Regulatory Affairs
HOW TO JOIN THE DISTANCE PARTICIATION PROGRAMHOW TO JOIN THE DISTANCE PARTICIATION PROGRAMIN PHARMA REGULATORY AFFAIRS ? IN PHARMA REGULATORY AFFAIRS ?
In order to join BII Industry Program in Pharma RegulatoryIn order to join BII Industry Program in Pharma RegulatoryAffairs the prospective participants has to submit the Affairs the prospective participants has to submit the necessarynecessaryform and the same can be downloaded from www.Bii.in form and the same can be downloaded from www.Bii.in
EligibilityEligibility The eligibilty for the training program is The eligibilty for the training program is graduation in any discipline.Highly interested participants in graduation in any discipline.Highly interested participants in final year can also apply. final year can also apply.
Program FeeProgram Fee BII Program Participation Fee for this BII Program Participation Fee for this program is Rs 10300 (for participants based in India / USD program is Rs 10300 (for participants based in India / USD 750 ( for overseas participants ). Payment is to be made 750 ( for overseas participants ). Payment is to be made through Demand Draft / Telegraphic Transfer in favor of through Demand Draft / Telegraphic Transfer in favor of Bioinformatics Institute of India Payable at Noida/DelhiBioinformatics Institute of India Payable at Noida/Delhi
Examination FeesExamination Fees Every student has to pay Rs.200/- per Every student has to pay Rs.200/- per module as examination fees . Examination fee for overseas module as examination fees . Examination fee for overseas participants is USD 25 Per Moduleparticipants is USD 25 Per Module
INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS
THANK YOUTHANK YOU
For Further Details And Enquiries Contact For Further Details And Enquiries Contact
Bioinformatics Institute Of IndiaBioinformatics Institute Of India
C-56A/28, Sector-62C-56A/28, Sector-62
Noida-2010301, U.P.Noida-2010301, U.P.
Tel:0120-4320801/02 Mobile:9818473366Tel:0120-4320801/02 Mobile:9818473366, , 98105353689810535368
Email: Email: [email protected]@bii.in
Visit: www.bii.inVisit: www.bii.in