www.samilabs.com Sami Labs Ltd Bangalore : Regulatory Affairs, USFDA, CTD, ANDA, IND, TGA, EMEA, ICH, Europe regulations

[mskavi]

Sami Labs Limited
http://www.samilabs.com

Keywords: Dossiers, Regulations for USFDA, CTD, ANDA, IND, TGA, EMEA, ICH, Europe regulations

Company Profile
Sami Labs is a research based Health Science Company with Subsidiaries in USA, Japan, Australia, South Africa, Germany, Middle East. Sami Labs is involved in the manufacturing and marketing of Speciality phytochemicals, nutraceuticals, cosmeceuticals

Vacancy for the post of Head - Regulatory Affairs

Experience: 8 - 13 Years
Location: Bengaluru/Bangalore
Education:
UG - B.Pharma - Pharmacy;B.Sc - Chemistry
PG - M.Pharma - Pharmacy;M.Sc - Chemistry
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
Posted Date: 08 Sep

Job Description
Compilation of regulatory dossiers for both domestic & international markets with good knowledge of principles, concepts, & structural details of USFDA, Europe regulations, CTD, ANDA, IND, TGA, EMEA, & ICH guidelines

Desired Candidate Profile
M.Pharm/M.Sc Chemistry/Ph.D with minimum 8 years of experience executing the role of Sr. Manager - Regulatory Affairs in a reputed pharma company.


Contact Details
Executive Name:
Nagajyothi

Address:
Sami Labs Limited
19/1, 1st Main, 2nd Phase,
Peenya Industrial Area
Bangalore,Karnataka,INDIA 58

Email Address:
jobs@samilabs.com

Telephone:
91-080-28397973

Reference ID:
Head-RA

[Guest]

CURRICULUM VITAE

S.KANNAN
Mobile no:9790727761
Email id: kanpharm82@yahoomail.co.in
________________________________________
CAREER OBJECTIVE

To procure a promising career that provides an opportunity to apply & enhance current skills, acquire new skills & contribute constructively to the organization

STRENGTHS

Technical and interpersonal skills, trustworthy, Ethical, Good interpersonal relationships.

Personal Profile

Father's Name : Mr. C. SHANMUGAM

Occupation : Driver

Mother’s Name : Mrs. S. VASANTHAMANI

Occupation : Home maker

Date of Birth : 22nd April, 1982

Gender : Male

Languages known : Tamil - Read, Write and Speak
English - Read, Write and Speak
Telugu – Speak,

Address for Communication : No- 1/177,KALAMPALAYAM,
PONGUPALAYAM(PO)
TIRUPPUR
TAMILNADU- 641666..

ACADEMIC QUALIFICATON
QUALIFICATION INSTITUTION YEAR OF PASSING PERCENTAGE ACQUIRED
10TH Thiruvalluvar Higher Sec. School, Periyayeepalayam. March 1997 79%
+2 Thiruvalluvar Higher Sec. School, Periyayeepalayam March 1999 71%
Diploma in Pharmacy Coimbatore medical college, coimbatore-14 Oct 1999-2001 67%
Bachelor of Pharmacy Madurai medical college, madurai-20. April 2002-2006 72%
Master of Pharmacy(biotechnology) Nandha College of Paramedical Sciences, Erode April 2007-2009 64%

ACADEMIC ACHIEWMENT
1. Submitted project works regarding “Formulation and Invitro Release studies of Diclofenac sodium Transdermal patch”.

2. Submitted project works regarding ”Screening for Antiviral Activity of Actinomycetes isolated from Soil sediments”.

EXPERIENCE
One year worked as professional service representative in top Indian multinational pharmaceutical company (GLENMARK PHARMACEUTICALS LTD)

DECLARATION
I solemnly pledge that the above-furnished information is true to the best of my knowledge and belief.

Place:

Date: (S. KANNAN )

[shyaminiep]

Curriculum vitae
SHYAMINI .E.P
Email:shyaminiep AT gmail.com

CAREER OBJECTIVE
- To be an expert in practical biotechnological techniques.

LINGUISTIC EXCELLENCE
Mother Tongue: Malayalam
Languages known: English, Malayalam, Tamil, Hindi

Educational Qualification
S.No Degree Obtained Board/university Year of
passing Percentage

1 10th
CBSE Sree valluvanad vidya bhavan,perintalmanna,
Malappuram district 2002 67
2 12th
CBSE Sree valluvanad vidya bhavan,perintalmanna 2004 68
3 B.Sc.
Plant science NSS College,Manjeri
Calicut University 2007 75
4 M.Sc
Biotechnology RVS College of Arts and Science - Coimbatore
( Bharathiar university ) Doing
1st semester
2ndsemester
3rd semester 4th semester-result awaiting.

Training Undergone
Training underwent Institute/University Duration
PCR & DNA FINGER PRINTING Trinity institute for biotech research, cochin, kerala 7 Days
TISSUE CULTURE AND MOLECULAR BIOLOGICAL STUDIES
Bioinformatics workshop Kerala University,Kariavattom,Trivandrum 15 days
2 days

Subject Knowledge
- Biotechnology Theories and Techniques
- Genetic Engineering, Genetics,Cell Biology
- Bioprocess Technology, Microbiology,Immunology
- Biochemistry,Molecular Biology
- Computer Fundamentals ,Basic Mathematics
- Recombinant DNA Technology

Practical Knowledge
- Plant Tissue Culture
- Pathology & Biochemical Analysis,ELISA
- Fermentative production of Wine,Immunological Techniques
- SDS - PAGE, Polymerase Chain Reaction,
- Southern Blotting, Western Blotting, Isolation and Purification of DNA from Plant Microbes and animals
- Isolation of Plasmid DNA ,Isolation of DNA from Phages
- Competent Cell Preparation,Restriction Digestion and Ligation of DNA
- Preparation of Media , staining Techniques, biochemical Tests
- Well knowledge in Handling of biotechnology related instruments
- Qualitative and Quantitative estimation of proteins sugars and AminoAcids

Personal Profile
Name: Shyamini.E.P
Nationality: Indian

Extra Curricular Activities
- Poster Presentation, Paper precentations,Seminars
- NCC

Presentation / Seminars Name of the College UG/PG Year
National conference on Pharmaceutical Biotechnology Karpagam Arts and Science college, Eachanari, Coimbatore 641021 PG Sep 27 & 28
2007
National seminar on Current trends in advanced Biological research (CTAB-2008) Poster Presentation
Nehru Arts and Science College, Thirumalayampalayam,Coimbatore 641105 PG Jan 24 & 25
2008
National seminar on Recent advances in plant Biology and Biotechnology.

paper presentation
Government Arts College, Coimbatore 641018 PG Feb 29 2008

Personal strength
- Hard work
- Team guiding
- Dedication
- Sincere, Truthful
Hobbies
- Music
- Photography

Reference
- Mr. M.P.Ayyappa Das
Head of the Department,
RVS College of Arts and Science,
Sulur, Coimbatore-641402.
Dr.Prasanna Kumar
Head of the Department
NSS College
Manjeri

Declaration
I here by declare that the above given particulars are true to my Knowledge, also assure that I will discharge my duties to the entire satisfaction of your concern.

Thanking you
Yours sincerely

[Guest]

an accet to your company

[kalpanab_malli@redif]

B.KALPANA
M.Pharm

CAREER HIGHLIGHTS:
Two years six months of rich experience in Regulatory Affairs Aurobindo Pharma Ltd.

Excellent research background with M.Pharm (PHARMACEUTICS) Post Graduate qualification
v Well versed in pharma standards and industry practices
v Excellent written & verbal communication skills

Experience Profile Organization Designation Period

- Vagdevi College of Pharmacy Lecturer July-2003 to Dec-2004Aurobindo Pharma Ltd,Hyderbad,India.

Research Associate-III (Regulatory Affairs) Jan-2005 to Jun-2007

PHARMA INDUSTRY EXPERIENCE:
Aurobindo Pharma Ltd
Responsibilities
v Preparation and Review of Registration Dossiers as per European Union requirement (IN CTD format).
v Successfully involved in National/MRP/DCP Procedures for European countries.
v Compilation, review and preparation of Module-5 & Module-4 (CTD) of Marketing Authorisation application for EU countries.
v Preparation of Summary of Product Characteristics, PIL, Labeling (1.3.1 sections of Module 1 (CTD)) of various Marketing Authorization applications for EU countries.
v Preparation and review of text for Artworks (1.3.2 sections of Module 1 (CTD)) of various Marketing Authorization applications for EU countries including Braille Mock ups.
v Preparation of Clinical & Non-clinical Overviews (Module 2.1- 2.7) of CTD.
v Review of documentssuch as Batch manufacturing records, Stability protocols, Specifications, Validation protocols and reports of process as well as analytical method for regulatory compliance (Module 3).
v Updating registration dossiers, evaluation of the queries received from respective country agencies and to respond for timely reply.
v Preparation of electronic format of CTD for E-submission in various EU Medical agencies.
v Preparation of customer specific Dossiers.
v Liaison with various departments like R&D, Bioanalytical, Clinical, Packaging, QC, QA, Production.
v Exposure to all the sections of module 1and variations.
v To prepare and distribute the schedule to the concerned departments for providing the technical data for registration and re-registration of the products. To update the database and to inform the concerned departments after registration of the products.
v Have knowledge on the all modules of CTD.

ACHIEVEMENTS:
v Active team member in filing of 15 Registration dossiers (By National, Decentralized & Mutual recognition procedures)
v Successful team member in receiving approvals for Paroxetine Tablets, Sumatriptan Tablets and Finasteride Tablets etc.

COMPUTER FAMILIARITY:
v Ms-office, windos, Lotus notes, Microsoft Out look & Internet.
EDUCATIONAL QUALIFICATIONS:

DegreeCollege & UniversityDuration%

M. Pharmacy (PHARMACEUTICS) Sri Venkateswara University 2007 July – 2009 March. 73.5
B .Pharmacy
Sri Padmavathi College of Pharmacy, Tirupati, JNTU, Hyderabad, Andhra Pradesh.
1999 Feb – 2003 June. 75

PROJECT DETAILS:
Preparation and Evaluation of sustained Release matrix tablets of Mefenamic Acid.

PERSONAL DETAILS:
Husband’s Name : D. Mallikarjuna Rao
DOB : 16-10 -1981.
Marital Status : Married
Languages Known : English, Telugu, Tamil & Hindi
Hobbies : Listening to Music, watching TV.

REFERENCES:
Mr. M.Puroshothaman,
Principal,
Rao’s college of Pharmacy,
Nellore, A.P.

Mr. Manoj .M. Jadav,
Team Leader, Regulatory Affairs Department,
Aurobindo Pharma Limited,
Hyderabad.

Declaration:
I solemnly declare that details furnished above are fully correct to the best of my knowledge.

Yours faithfully
Date:
(B.Kalpana)

[archanakhanagwal]

Archana
M. Pharm. (Pharmaceutics –drug regulatory affairs) from Maharishi Dayanand University, Rohtak

OBJECTIVE
To seek challenging position and to dedicate my services to a reputed organization to expose my talent and skills.

EDUCATION
Professional Qualification:
1. Graduate in Pharmaceutical Sciences (67%) from GURU JAMBESHWAR UNIVERSITYof Science & technology,Hissar. (Session: 2004-2008)
2. PURSUING 1 month course in PATENT and TRADEMARK from WIPO.
3. Worked on “ ACCELERATED DEVELOPMENT OF ORPHAN DRUGS: GLOBAL ISSUES & REGULATORY CONTROL” IN m.pharma.

Academic Qualification
Exam Year of Passing Board/University Percentage
Matriculation 2001 C.B.S.E 58%
Sr. Sec. Examination 2004 C.B.S.E 60%
B. Pharmacy 2008 G.J.U S&T,Hissar 67%(aggregate)
m.pharmacy 2010 M.D.U,Rohtak 63%
GATE 2008 IISE, Bangalore Qualified

COMPUTER SKILLS
- Internet usage
- Knowledge of MS-Office

Curriculum Vitae
INDUSTRIAL TRAINING AND VISIT
UNDERGONE INPLANT TRAINING IN :
1 JRS ORYX , Karnal
UNDER GONE VISIT IN:
1 TORRENT PHARMACEUTICAL - AHMEDABAD
2 ZYDUS CADILLA – AHMEDABAD
3 MONOCHEM PHARMACEUTICALS - AHMEDABAD

SEMINARS
Delivered an seminar on “INVESTIGATIONAL NEW DRUG APPLICATION (IND)” & “DRUG AND COSMETIC ACT 1940”.

PROJECTS PREPARED
1. Prepared project report in b.pharma final year on “PHARMACOECONOMICS”.
2. Prepared project report on m.pharma on “FILLING AN IND for new chemical substance”.
3. Prepared project report on “FILLING AN APPLICATION FOR OTC DRUG PRODUCT”.
4. Prepared project report on “ ANDA(ABBREVIATED NEW DRUG APPLICATION)”.
5. Prepared project report on “ BIOLOGIC LICENCE APPLICATION”.

EXTRA CURRICULUR ACTIVITIES
1 Attended IPC (INDIAN PHARMACY COUNCIL) held at Delhi as a delegate
2 Participated in National Pharmacy Week helded at M.D.U. Rohtak
3 Attended IPC (INDIAN PHARMACY COUNCIL) held at ahmedabad

AREA OF INTEREST
1 Regulatory affairs
2 Production
3 Clinical Research & trial

STRENGH
1. Positive Attitude, flexible nature and Making Friends
2. Ability to live and work in a group excellently
3. Passionate about my work.

DECLARATION
I hereby declare that the above-mentioned information is true to the best of my knowledge.

Date : 8.4.2010
Place : karnal (Archana)

[Guest]

CURRICULUM VITAE

Ramandeep Kaur
ramandeep.dra AT gmail.com

OBJECTIVE:
To grow professionally and share responsibilities by contributing my efforts for the achievement of the goals set by organization using my knowledge and technical skills.


WORKING EXPERIENCE: (Total – 6+ Years)

1. Nature of Work : Scientist-I - Regulatory Affairs
Market : Europe
Company : Aurobindo Pharma Limited
Experience : October 2007 till date
Location : Hyderabad, Andhra Pradesh

2. Nature of Work : Scientist-II - Regulatory Affairs
Market : Europe
Company : Torrent Research Centre
Experience : December 2006 to October 2007
Location : Ahmedabad, Gujarat

3. Nature of Work : Research Associate - Regulatory Affairs
Market : US, Europe, Canada, Japan, Korea.
Company : Ind-Swift Laboratories Limited
Experience : June 2004 to December 2006
Location : Mohali, Punjab

JOB RESPONSIBILITIES: (AUROBINDO PHARMA LIMITED)

- Review of technical documents required for filing [viz., product development reports, manufacturing formula cards, process validation reports, specifications of drug substance, drug product, excipients and packaging materials, analytical method validation reports, stability protocols and stability data]
- Compilation of Registration dossiers [Quality part] in various EU formats viz., NeeS, eCTD, Portuguese and CTD formats.
- Submission of Registration dossiers in National, Mutual Recognition and Decentralized procedures
- Responding to agency queries (quality related) for the ongoing registrations under National, Mutual recognition and Decentralized procedures.
- Handling of post approval activities viz., intimation of product approval information to the concerned for implementation of the approved details during commercialization.
- Filing of variation applications in accordance with the current guidelines on dossier requirements of Type IA/Type IB/ Type II variations.
- Submission of quality related documents for product renewals.
- Updating of dossiers for Mutual recognition procedures and Duplicate applications.
- Preparation of tailor made customer specific dossiers.
- Maintenance of database for life cycle of the products viz., status of filings, approval details, approved variations, compliance of post approval commitments, etc.
- Training of subordinates in review/updating of the registration dossiers for filing and updating their knowledge on current guidelines (viz., ICH, EMEA etc).

JOB RESPONSIBILITIES: (TORRENT RESEARCH CENTRE)

- Preparation and submission of Certificates of Suitability & European Drug Master Files.
- Handling and responding to Technical queries related to Drug substance from various Regulatory Authorities.
- Review and finalization of specification of raw materials, intermediates and final drug substance.
- Review of various documents related to Drug substance viz. AMV, MFC, IPS, PDR, TTD, PVP etc. from Regulatory perspective.
- Co-ordination with various departments to collect documents in order to facilitate the in-time registrations.
- Review and finalization of outsourced DMFs.

JOB RESPONSIBILITIES: (IND-SWIFT LABS LIMITED)

- Preparation and submission of US Drug Master Files (CTD-Format).
- Preparation and submission of Ph. Eur. Certificates of Suitability.
- Preparation and submission of European Drug Master Files, Korean Drug Master, Files, Canadian Drug Master Files and Japanese Drug Master Files in CTD-Format.
- Handling and responding to Technical queries from various Regulatory Authorities.
- Co-ordination with various departments to collect documents in order to facilitate the in-time registrations.


ACADEMIC QUALIFICATION:
- Masters in Pharmacy from University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, April 2004, O grade (equivalent to 80%)
- Bachelors in Pharmacy from Guru Nanak Dev University, Amritsar, Punjab, April 2002, 70%

ACADEMIC AWARDS/ACHIEVEMENTS
- Qualified GATE (Graduate Aptitude Test of Engineering) 2002
- Granted financial assistance by the AICTE, New Delhi, for carrying out research project in M. Pharm (2002-2004).

RESEARCH EXPERIENCE:
- Submitted thesis by research on “Phytochemical investigations and detoxification studies of Ayurvedic drug “Atis” (Aconitum heterophyllum)” for the award of M. Pharmacy degree under the guidance of Prof. Dr. Karan Vashisht, Univeristy Institute of Pharmaceutical Sciences, Panjab university, Chandigarh.

PERSONAL DETAILS:
Name : Ramandeep Kaur
Husband’s Name : S. Guriqbal Singh
Date of Birth : 31-08-1980
Nationality : Indian
Language Known : English, Punjabi and Hindi


DECLARATION:
I do hereby declare that the above mentioned facts are true to the best of my knowledge and belief.

Thanking you,


Place: Yours Truly,
Date:
(Ramandeep Kaur)

[Guest]

P.R.K.VISWESWARA RAO.K
M.Pharmacy (Pharmaceutical Analysis)
E-mail : viswa.pandu AT gmail.com

Sub : - Application for the suitable position in your Organization.
I take this opportunity to introduce myself a P.R.K.VISWESWARA RAO.K did my M.Pharmacy (PHARMACEUTICAL ANALYSIS) in NAGARJUNA UNIVERSITY,GUNTUR, did my project work in “CHANDRA LABS”, HYDERABAD, during academic period 2010 -2011, for a period of six months.
I have interest to work in your organization, with the knowledge and practical skills gained during my studies. I am sure that i am competent enough to fulfill the needs and demands of your esteemed organization. I will be very grateful to you if you consider my application for a position in your organization.
I am herewith enclosing my Curriculum Vitae for your kind consideration and favour. Looking forward to be a part of your organization.
CURRICULAM VITTAE
K.PRK Visweswara Rao
E-mail : viswa.pandu AT gmail.com
CAREER OBJECTIVE
To work with progressive organization that gives me the opportunity where I can utilize my skills in achieving targets and to face challenges in a common goal of organization with bright professional career.
EDUCATIONAL QUALIFICATIONS :
M.Pharmacy : Nagarjuna university,Guntur 80%
(Pharmaceutical analysis)
B.Pharmacy : Ultra College of Pharmacy, Madurai. 70%
D.Pharmacy : Niveditha College of Pharmacy,Banglore 65%
Intermediate : B.B.H.Jr.College ,Vetapalem 75%
S.S.C : B.B.H.Jr.college ,Vetapalem 80%
GATE-2009 Qualified, PERSENTILE SCORE 87%
PROJECT :
- Validated liquid chromatographic method for simultaneous estimation of Zolpidem tartarate and Melatonin in tablet dosage form.
- Pharmcognostical and Pharmacological studies ,Anti-inflamatory and Antipyretic activity on the leaves extract of Anisomeles malabarica
TRAINING SKILLS :
- Experience in pharmacy one year.
- Trained in Area Hospital,Chirala -3 months.
COMPUTER SKILLS :
- MS-Office
- C-language
- Tally-7.2
CONFERENCE SKILLS :
- As participant in Indian Phrmaceutical Conference-08.
New Delhi.
- As participant in International Seminor on Medicinal plants and Herbal products,Tirupathi.

[Guest]

CURRICULAM VITAE
U.LAKSHMI VENKATESULU
E-mail ID : lakshmi_venkat55 AT yahoo.com

Summary : I have 4.6 years functional experience in Quality control department
OBJECTIVE
Looking forward to associate myself with an organization where there is an opportunity to share, contribute and upgrade my knowledge for the development of self and organization served..
EDUCATIONAL PROFILE
M.Sc. ( Microbiology) from Sri Krishna devaraya University, Anantapur.
B.Sc. (Microbiology) from SSBN Degree college, Anantapur.
Intermediate BiPC from Board of Intermediate, Kalyanadurgam.
S.S.C. from Board of Secondary school certificate, Thimmapuram.
JOB EXPERIENCE
- Currently working in Aurobindo Pharma Limited, Unit-VI (API/Formulation ) as a chemist in Quality Control Department from Nov-2007 to till date. (AUROBINDO PHARMA LTD manufacturing Sterile API Cephalosporins. )
- Project work on Quality control Department in NATCO PHARMA from Aug 2007 to
Oct 2007.
JOB RESPONSIBILITIES :
- Analysis of Raw materials, Intermediates and Finished Products as per specifications.
- Working standards preparations
- Documentation of API & Intermediates as per regulatory requirement and In House Specifications.
- Preparation of Certificate of Analysis and checking of all documents related to the Certificate of Analysis.
- Responsible for the routine calibration of instruments as per schedule.
- Responsible for Review and Maintenance of instrument log books and ATDS

INSTRUMENTS HANDLED
Gas Chromatography
Instrument : Shimadzu GC 2010 ,Agilent 6900
Software : GC Solutions , Chemistations

High Performance Liquid Chromatography
Instrument : Shimadzu LC 2010 Waters2695
Software : LC Solutions Empower
Digital kF Meter (Metrohm ,795-KF Titrino)
U.V spectrometer (Shimadzu,UV-1700)
F T I R (Perkin Elmer, Spectrum One)
Polari meter (Horiba, Sepa-300)
Bulk density apparatus

Instrument Calibrations :
- GC. (Shimadzu GC-2010)
- HPLC (shimadzu LC-2010)
- FTIR(Perkin elemer)
- Polarimeter(Horiba)
- Calibration of Micro Balance & Analytical Balance.(Saratorius)
- Calibration of UV, Visible spectrphotometar
OTHERS
Computer Knowledge MS office,
Languages Known English , Telugu, Kannada and Hindi
STRENGTHS
- I am very Enthusiastic in learning things
- Obedient with superiors and cooperative at any situation
- Having good documentation skills as per GLP
- Taken the responsibility of GLP in working laboratory

DECLARATION
I here by declare that the above mentioned information is correct up to my knowledge.
(VENKAT)
Place : Hyderabad