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INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS (12 MONTHS DISTANCE PARTICIPATION PROGRAM) (12 MONTHS DISTANCE PARTICIPATION PROGRAM) BATCH- VIIth BATCH- VIIth Offered by: Bioinformatics Institute Of India Offered by: Bioinformatics Institute Of India

Pharma Regulatory Affairs

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Page 1: Pharma Regulatory Affairs

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

Page 2: Pharma Regulatory Affairs

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

Page 3: 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

Page 4: 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

Page 5: 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

Page 6: Pharma Regulatory Affairs

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

Page 7: Pharma Regulatory Affairs

COURSEWARE OFFERED BY BII COURSEWARE OFFERED BY BII

BOOKSBOOKS

INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS

Page 8: Pharma Regulatory Affairs

MULTIMEDIA CDs

INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS

Page 9: Pharma Regulatory Affairs

PROGRAM METHODOLOGYPROGRAM METHODOLOGY

INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS

Page 10: 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

Page 11: Pharma Regulatory Affairs
Page 12: Pharma Regulatory Affairs

. . 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

Page 13: 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

Page 14: 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

Page 15: 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

Page 16: 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

Page 17: Pharma 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

Page 18: Pharma 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

Page 19: Pharma Regulatory Affairs

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

Page 20: Pharma Regulatory 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

Page 21: Pharma 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

Page 22: Pharma 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

Page 23: 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