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Vacancy for M.Pharm, M.Sc at National Dope Testing Laboratory | 04 posts

NDTL has state of the art facilities for research and is engaged in conducting research on various projects. The research papers are presented in the International and National conferences and published in indexed journals. However, the first ever Ph.D. thesis of Madhusudan Reddy (Detectability of Indian glucocorticosteroid preparations in sports persons: Effect on the endogenous steroid profile…

Recruitment for M.Pharm, Pharm.D to work as Research Assistant at Manipal College of Pharmaceutical Sciences

Applications are invited from the eligible candidates for the position of Research assistant under Dr. Girish Thunga for the project entitled “Quality use of medicines initiatives for metabolic monitoring of antipsychotics ” at the Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal. The project is sponsored by Griffith University, Gold coast QLD 4222, Australia.

Post : RESEARCH ASSISTANT

Job for Lecturers (4 posts) in Sri Sai Institute of Pharmacy

Sri Sai Institute of Pharmacy College was established in the year 2008-09, and duly approved by the AICTE & PHARMACY COUNCIL OF INDIA (PCI) u/s 12, Gov. of India and is affiliated to Board of Technical Education U.P., Lucknow with 60 students strength. S.S.I.P. is only P.C.I. approved D.Pharma college in Aligarh region.

Post: Lecturer 04

Medistar hospital require Clinical Research coordinator

Medistar hospital is committed to achieve excellence in health care by providing the latest technology for diagnostic and therapeutic services, set up with superior ambience. Employing a team of highly qualified and committed consultants and paramedical staff, combined with state-of-the art technology. The hospital ensures quality medical care to meet the demands of different age groups and risk profiles.

Post : Clinical Research coordinator

Recruitment for freshers M.Pharma, M.Sc as Trainee Associate Scientist at Novartis

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : Trainee Associate Scientist

Career for M.Pharm, M.Sc in Department of Clinical Pharmacology at SRM Medical College Hospital & Research Centre

Applications are invited for suitable candidates for the position of Senior Research Fellow (SRF) to work on the following ICMR sponsored research project titled “Evaluation of Evaluation of a Multi-Marker Strategy to Prognosticate patients with Acute coronary Syndrome” under the supervision of Dr. Melvin George, Assistant Professor, Department of Clinical Pharmacology, SRM Medical College Hospital & Research Centre, Kattankulathur-603202, Kancheepuram

Post: Senior Research Fellow

Vacancy for Zonal manager / Area manager at Mankind Pharma

Vet Mankind A div of Mankind pharma ltd

Post : Zonal manager / Area manager

Walk in interview in Quality Control, Quality Assurance, Production at Alkem Laboratories | M.Pharm, B.Pharm, M.Sc

Alkem Laboratories Limited, established in 1973, a Top Ten leading Indian Pharmaceutical Company with global operations, engaged in the development, manufacture and sale of pharmaceutical and neutraceutical products, which is marketed in India and 55 countries internationally, primarily in the United States. Our domestic business has grown at a CAGR of 17.6% from fiscal year 2011 to fiscal year 2015. Approved by US-FDA, MHRA and other regulatory authorities, we are looking for Energetic, Enthusiastic & Motivated personnel for our formulation unit in Daman.

Applications Invited for the Post of Pharmacist at Manipal University

Manipal, today, is a knowledge powerhouse and a brand name in higher education. Over five and half decades ago, one man, Dr Tonse Madhava Anantha Pai, had a vision which ensured that everything he did then, was consigned to posterity, making sure that generation after generation of students enjoy the fruits of his labour till eternity on this lateritic plateau. And the students will, forever, have one name on their lips, that of Manipal.

Recruitment for Medical Represenative, Area Business Manager at Panacea Biotec | All over India

Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.

Job for Product Manager at Aspiring Solutions

Our client is a vibrant fast growing pharma co.

Post : Product Manager (Ortho/ Food Supplements)

Working Opportunity at MSD as Assoc Director, GRACS External Operations

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Post : Assoc Director, GRACS External Operations / Local Supplier

AN APPROVAL TO MANUFACTURE AND SALE THE COPY OF INNOVATOR PRODUCT IN THE US MARKET

{ DOWNLOAD AS PDF }

ABOUT AUTHORS
MUNISH THAKUR*,  Dr. ANUPAMA SETIA, Ms. NEETU.
DEPARTMENT OF PHARMACEUTICAL MANAGEMENT &
 DRUG REGULATORY AFFAIRS,
JCDM COLLEGE OF PHARMACY,
SIRSA-HARYANA (INDIA).
munish.thakur98@gmail.com

ABSTRACT
The drug designated for production has to be manufactured in compliance with Current Good Manufacturing Practices (cGMP) following USFDA requirements, EU Directive or International Conference on Harmonization (ICH) Guidelines or Regulatory Authority of respective country. Regulatory authorities bear the responsibility to conduct inspections on pharmaceutical manufacturing plants to ensure they follows cGMP guidelines so that the drug manufactured is safe and effective. A quality system has to be set up such that the drug is manufactured in accordance with approved procedures. A drug is not permitted for sale until the marketing application for the new drug has been reviewed and approved by regulatory authorities. Extensive dossiers are provided to the authorities to demonstrate the safety, potency, efficacy and purity of the drug. After the drug has been approved and marketed, there is continuous monitoring of the safety and performance of the drug to ensure that it is prescribed correctly and adverse events (side effects) are investigated. The United States Food and Drugs Administration (FDA) has one of the most comprehensive and transparent regulatory systems in the world. In US Common Technical Document (CTD) format and most recently its electronic version-the electronic Common Technical Document (eCTD) format is used for submission of dossiers. Inclusion of a paragraph IV certification permits the Applicant to file its ANDA 4 years after the approval of a new chemical entity that is 1 year before the actual expiry of the 5 years exclusivity. In case patent exists that claims the drug, drug product, or method of use, the applicant is requested to file a patent certification with regards to the patent status. The different types of patent certifications are discussed. This project work elucidates US FDA’s previous interpretations of the statute regarding 180 days exclusivity and latest amendments in the current guidance. Information considered helpful in the compilation of different CTD modules 1, 2, 3, and 5 is discussed. Electronic submission in eCTD format is outlined.

National workshop on “National workshop on molecular method PCR & RT-PCR Techniques at ADINA Institute of Pharmaceutical Sciences

ABOUT INSTITUTE
ADINA Institute of Pharmaceutical Sciences was established in 2005 under aegis of Shri. Prem Chand Jain Memorial Society For Education. We are providing research oriented education in its fully wi-fi campus, experienced faculty members as per the norms and standards of AICTE, PCI and RGPV. AIPS has mordem lecture halls, well equipped laboratories, e-library, computer labs with internet facility. It is an ISO 9001 : 2000 certified institute, it is offering B. Pharm & M. Pharm in three disclipine : Pharmaceutics, Pharmaceutical chemistry and Pharmacology.

Recruitment for Pharmacists (04 posts) in Health Medical & Family Welfare Department | Government Job

Applications are invited from the qualified and eligible candidates for filling up of the following vacancies on Contract basis, initially for a period of six months to discharge their duties in I.T.D.A., Parvathipuram Area and roster points in Health Medical & Family Welfare Department, Government of Andhra Pradesh. Applications may be sent to the DM&HO., Vizianagaram for which application is made.

Post : Pharmacist Gr.II

Job for Pharmacist at Ram Manohar Lohia Institute of Medical Sciences

Dr Ram Manohar Lohia Institute of Medical Sciences is centrally located in Vibhuti Khand, Gomti Nagar, Lucknow. The hospital affiliated to the institute offers high end services and treatment in various superspeciality medical disciplines and also offers teaching facilities imparting degrees of D.M., M.Ch., M.D., M.S., Ph.D. as well as paramedical diploma programs.

Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, an autonomous Institute of U.P. Govt. invites Online applications on prescribed format for the posts mentioned as below.

Post : Pharmacist (GEN 01 post)

Career for Clinical Data Manager at Indegene

Indegene is a recognized global leader in providing noticeable healthcare solutions and services and partner to some of the largest and most respected healthcare organizations. Being associated with Indegene, an equal opportunity employer, is about making tangible contributions with a focus to deliver outcomes that are measurable, impactful, and sustainable. We are a team of more than 1,200 employees across 14 global locations.

Post : Clinical Data Manager

Vacancy for Health Care Executive at Eisai

Eisai Inc. is a U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of approximately $3.9 billion in fiscal year 2009 (year ending March 31, 2010).

Post : Health Care Executive

Opportunity for Freshers in Cactus Global for the post of Associate, Project Management

CACTUS is a pioneering global scientific communications company. In everything we do, we want to accelerate the development of global scientific research, by helping science break through the confines of geography and language. To this end, we partner with academic and pharmaceutical communities worldwide and leverage the expertise of 1400+ professionals to create compelling, high-quality scientific communications. Browse through the tabs below for a closer look at CACTUS.

Post: Associate, Project Management

Novartis requires professionals with pharmaceutical experience as Regulatory Coordinator

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : Regulatory Coordinator

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