www.neulandlabs.com Neuland Laboratories Ltd Hyderabad : Bulk Drugs Regulatory Affairs Manager

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  1. Post Count Number #1
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    www.neulandlabs.com Neuland Laboratories Ltd Hyderabad : Bulk Drugs Regulatory Affairs Manager

    Neuland Laboratories Ltd Hyderabad / Secunderabad : Deputy Manager for Regulatory Affairs

    Website: http://www.neulandlabs.com

    Keywords: Deputy Manager for Regulatory Affairs, API, Bulk Drugs

    Designation: Deputy Manager for Regulatory Affairs
    Experience: 6 - 8 Years
    Location: Hyderabad / Secunderabad
    Education:
    UG - Graduation Not Required
    PG - M.Sc - Chemistry
    Industry Type: Pharma/ Biotech/Clinical Research
    Functional Area: Healthcare, Medical, R&D
    Posted Date: 03 Mar

    Job Description:
    Preparation and Submission of Drug Master Files, technical date packages, preparation of updates of different Active Pharmaceutical Ingredients (API's) for filing purpose to Regulatory Authorities of Various countries as per global regulatory requirements. Review, compilation and submission of documents in a scheduled time frame to regulatory agencies through regulatory agents. Proactive review of documents and data generation for anticipated queries and ensuring quick response to queries received from different regulatory bodies and customer to expedite the approval process. He would play an active role in supporting ISMS implementation program. Position is in our USFDA inspected facilities at Hyderabad.

    Desired Candidate Profile:
    M.Sc in Chemistry with 6-8 Years experiance Post Qualification in Regulatory Affairs with Bulk Drug companies. This position reports to the Senior Manager - Regulatory Affairs.

    Company Profile:
    Neuland (Laboratories Limited) is a quality conscious and research driven, reliable Active Pharmaceutical Ingredients manufacturing company, specializing in Contract Research and Manufacturing. (In business) since 23 years, Neuland is a preferred source for all the major generic companies across the globe. Neuland, a $50 Million company, having the largest market share of Ciprofloxacin Hcl in US & Europe has close to 25 products across 8 different therapeutic segments in our portfolio.

    Neuland's multi-product manufacturing facilities at Bonthapally and Pashamylaram (close to Hyderabad) are inspected and approved by USFDA and both the units also boast GMP approval from TGA, Australia. Neuland has been accredited with COS from EDQM for Eight of its API's across four therapeutic categories. Neuland services more than 800 customers spread across 80 countries.

    Neuland with 27 USDMF's and more than 305 DMF filings with various Health Authorities across Europe and other regulated markets is testimony enough to Neuland's unrelenting commitment for being and continuing to be a preferred source worldwide.

    Executive Name: Mr.Ravikant

    Address:
    Not Mentioned

    Email Address: careers@neulandlabs.com

    Telephone: Not Mentioned

    Reference ID:
    QCQA/U1/RA-Deputy Manager

    Keywords: Deputy Manager for Regulatory Affairs, API, Bulk Drugs
    Last edited by Guest-IJT; May 13th, 2011 at 03:20 PM.

  2. Post Count Number #2
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    Re: Neuland Laboratories Hyderabad : Bulk Drugs Regulatory Affairs Manager

    MD ARIF PASHA,
    H.No: 6-2-434,
    Hussainipura, karkhanagadda,
    Karimnagar.
    Email: arif.mohdpasha AT gmail.com
    Tel : 09849441077, 09492812007.


    Dept. of Human Resources
    Dear Sir or Madam:
    I am a fresh postgraduate student in Pharmaceutical Chemistry and am currently exploring job opportunities. As my resume reveals, I have both a Bachelors and Master's degree in Pharmacy. I enjoy working in a high energy and high performance work environment.
    I have enclosed my resume for your review. I would like the opportunity to meet and share more about my qualifications and the ways in which I can contribute to the team.
    Thank you for your consideration.
    Sincerely,
    MD. Arif Pasha.

    CURRICULUM VITTAE

    MD ARIF PASHA,
    H.No: 6-2-434,
    Hussainipura, karkhanagadda,
    Karimnagar.
    Email: arif.mohdpasha AT gmail.com
    Tel : 09849441077, 09492812007.

    Objective

    To excel in my field of work by utilizing the skills that I have gained so far and by putting in sincerity and hard work to fulfill all the organizational objectives, to become an asset to the organization that I work in and there on rise to the high managerial levels.

    Educational qualifications


    Institution Examination Board/University Year of Passing Marks Obtained
    J.K.K.Nataraja College of Pharmacy, Komarapalayam MASTER OF PHARMACY
    (Pharmaceutical Chemistry )
    Dr M.G.R Medical University, Chennai March 2009 77.1%
    S.S.R. College of Pharmacy, Mahabubnagar BACHELOR OF PHARMACY Osmania University, Hyderabad May 2007 67.7%
    Trinity Junior College, Karimnagar INTERMEDIATE Board of Intermediate Education, Hyderabad March 2001 71.9%

    Vaniniketan High school,Karimnagar S.S.C. Board of Secondary Education, Hyderabad March 1999 71.6%

    Project
    M.Pharm Thesis : Phytochemical characterization and pharmacological evaluation of Pseudarthria viscida Linn.


    Institute : J.K.K.Nataraja College of Pharmacy, komarapalayam, Tamil Nadu.
    Team size : 1
    Duration : 1 year
    Areas of Interest
    Quality Assurance, Research & Development, Quality Control, Production, Regulatory affairs.

    Professional Skills
    - I have basic knowledge on modern instrumentation analytical equipments like (HPLC, UV, FT-NMR, FT-IR)

    Conventions Attended
    - DDPR International symposium at K.L.E College of Pharmacy, 2006 held at Belgaum.
    - IPA Education division seminar at Vinayaka Missions University, 2007 held at Salem.
    - IPA at DIPSAR, 2009 held at Delhi.

    Poster Presentation
    - Poster presented in 58th IPC, 2006 held at Mumbai.
    - Poster presented in APTI, 2007 held at Chandigarh.
    - Poster presented in PES College of Pharmacy, 2008 held at Bangalore.
    - Poster presented in Nehru College of Pharmacy, 2009 held at Pampady, Kerala.
    - Poster presented in MNR College of Pharmacy, 2009 held at Sanga Reddy.

    PERSONAL PROFILE

    Date of Birth : 27 –11-1983
    Nationality : Indian
    Religion : Muslim
    Marital Status : Single
    Gender : Male
    Languages Known : English, Hindi, and Telugu
    Computer Education : Microsoft Word, Excel & Power Point


    Reference’s

    G.A. Prasad Anil Kumar,
    Drug Inspector.

    P.Perumal, M.Pharm, PhD, AIC.
    Principal,
    J.K.K.Nataraja College of Pharmacy,
    Komarapalayam.

    R.Suthakarn, M.Pharm, PhD.
    Principal,
    S.S.R. College of Pharmacy,
    Mahabubnagar.

    Manjunathan, M.Pharm, PhD.
    Principal,
    Srinivasa College of Pharmacy,
    Vikarabad.

    MD ARIF PASHA

  3. Post Count Number #3
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    July 25th, 2010
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    Re: Neuland Laboratories Hyderabad : Bulk Drugs Regulatory Affairs Manager

    MADIKATTU KALPANA Email: kalpanampharm AT gmail.com

    Objective:
    To work in a challenging and dynamic environment where my skills are completely utilized and have a scope of continuous enhancement of skills and carrier growth.

    Profile:
    Research oriented, Self-motivated, Hard working, Punctual, Team spirit and Zeal to learn

    Educational Qualifications:

    COURSE UNIVERSITY/INSTITUTE ACADEMIC YEAR PERCENTAGE
    M.Pharmacy (Pharmaceutics) Sri Venkateshwara College of Pharmacy (Osmania University) 2006 - 2008 63%.
    B. Pharmacy Smt.Sarojini Ramulamma College of Pharmacy (Osmania University) 2002 –2006 75%.
    Intermediate(10+2) Siddhartha Junior College,
    Chanda nagar 1999 - 2001 71%.
    SSC (10) Jyothi Vidyalaya High School,
    Hyderabad 1998 -1999 73%.

    Achievements:
    - Qualified GATE–2006 with 1441 Rank ( 90%)
    Academical Knowledge:
    - Done a minor project on Development and Evaluation of Gastroretentive Dosage form for Ranitidine.
    - Experience in formulating Conventional Dosage, SR and some Novel Dosage Forms
    - Have a good knowledge in Preformulation studies and formulation development.

    Technical Knowledge:
    - Knowledge in MS Office.


    Dissertation Work:
    Formulation and Evaluation of Aceclofenac Semisolid matrix formulations by Liquid Filling Technology in Hard Gelatin Capsules.

    Industrial Training:
    I under took Industrial training for a period of 45 days in the manufacture of pharmaceuticals in ALLFARMA, Hyderabad.

    Area Of Interest:

    1. Formulation Research and Development
    2. Quality Assurance
    3. Regulatory Affairs

    Instruments Handled:

    - Tablet compression machine 10 stations.
    - Uv-Visible Spectrophotometer.
    - All tablet testing instruments including dissolution apparatus.
    - All laboratory instruments like pH meter, Potentimeter, Refractometer, TLC

    Seminars Delivered:
    - Protenoids.
    - Therapeutic Dental Devices.

    Personal Details:
    Father name : M. Jangaiah
    Date of Birth : 20-11-1983.
    Marital status : Single
    Languages Known : Telugu, English and Hindi.

  4. Post Count Number #4
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    msc analytical chemistry

    sir, i want a job.

  5. Post Count Number #5
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    Seeking for a challenging job in Regulatory affairs sector

    CURRICULUM VITAE
    PAVAN KUMAR DEVINENI,
    E-mail ID : devineni.pavan2007 AT gmail.com
    CAREER OBJECTIVE :
    To pursue a highly challenging career, where I can apply my existing knowledge and caliber, acquire new skills and contribute effectively to the organization.

    ACADEMIC PROFILE :
    - MASTER OF PHARMACY in PHARMACEUTICS from K.V.S.R. SIDDHARTHA COLLEGE OF PHARMACEUTICAL SCIENCES under affiliation of KRISHNA UNIVERSITY, A.P. with an aggregate of 85 % in 2012.
    - Awarded BACHELOR OF PHARMACY from KAKATIYA UNIVERSITY, A.P. with an aggregate of 80 % in 2010.
    - Secured an aggregate of 84 % in intermediate in Bi.P.C. stream through BOARD OF INTERMEDIATE (A.P.) examination in 2006.
    - Secured an aggregate of 73 % in tenth standard from CENTRAL BOARD OF SECONDARY EDUCATION (CHENNAI) examination in 2004.
    MY ABILITIES :
    - Well enriched in aspects of biopharmaceutics, pharmacokinetics and regulatory affairs and intellectual property rights.
    - Capable of performing preformulation studies, dissolution method development etc.
    - Experienced in handling UV double beam spectrophotometer, HPLC (LC solutions-PDA detector), dissolution apparatus, orbital rotary shaker incubator etc.
    - Have basic knowledge of computer regarding MS Office, ChemSketch etc.
    - Have a strong desire to work in challenging environment, where I can utilize my education and skills. To achieve this aim I am determined to offer honesty, sincerity and efficiency to the optimum level.
    - Self-disciplined, energetic and dedicated to work effectively within a team.
    - Always eager to learn innovative aspects.
    - Refer to national and international journals and publications very often and get accustomed to innovative aspects in various fields of pharmaceutical industry.
    MY DISSERTATION WORK :
    - M.PHARMACY : Studies on development of controlled release matrix tablets of Camptothecin - an anticancer drug.
    MY ACHEIVEMENTS :
    - Secured university top mark for M.PHARMACY dissertation work.
    - Stood college second in academics during B.PHARMACY course.

    MY PRESENTATIONS :
    - Presented a poster regarding the topic “GREEN CHEMISTRY : ORIGIN AND CHALLENGES”.
    - Oral seminar on the topic “GUIDANCE FOR INDUSTRY : DISSOLUTION TESTING OF IMMEDIATE RELEASE SOLID ORAL DOSAGE FORMS”.
    RESEARCH ARTICLES :
    - Studies on controlled release matrix tablets of camptothecin-an anticancer drug (SCIENTIA PHARMACEUTICA-negotiations under progress)
    - Development and evaluation of mouth dissolving films of amlodipine besylate for better therapeutic efficacy (DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY-negotiations under progress)
    SEMINARS ATTENDED :
    - Attended to seminar on Novel Drug Delivery Systems (NDDS) in INDIAN PHARMACY CONGRESS (IPC) in 2008 held at New Delhi.
    - Attended to seminar on Future Prospectus of Pharmaceutical Industry in India in INDIAN PHARMACY CONGRESS (IPC) in 2008 held at New Delhi.
    - Attended to seminar on analytical method development and operation of HPLC in SIDDHARTHA ANALYTICON in 2011 held at Vijayawada.
    - Attended to seminar on Intellectual Property Rights and Regulatory Guidelines presented by DEPUTY CONTROLLER OF PATENTS AND DESIGNS, CHENNAI PATENT OFFICE.
    - Attended seminar on Personality Development and Active Communication Skills.
    AREAS OF INTEREST :
    - Formulation Research and Development
    - Regulatory Affairs

    DECLARATION :
    I hereby declare that the above mentioned information is true to best of my knowledge and further information will be furnished if required.
    PAVAN KUMAR DEVINENI
    REFERENCES :
    - BUCHI N. NALLURI, PhD, Director for P.G. Studies and Research, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada.
    Email ID : buchinalluri AT yahoo.com
    - G.DEVALA RAO, PhD, Principal, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada.