Regulatory Affairs - Formulation Jobs in Rusan Pharma Ltd

By: Pharma Jobs | Views: 3944 | Date: 10-Feb-2016

Rusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. The company has its own Research & Development centre at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla having approval of MHRA (UK), MCC (SA) and other International Health Authorities. March 2008 - 82 Crs., Expected by Marc


Regulatory Affairs - Formulation - Rusan Pharma Ltd

Job Description 

    Position Vacant Manager Regulatory Affairs

    Organization Name RUSAN PHARMA LTD.

    Company Profile Rusan is a research driven pharmaceutical company having its Manufacturing Units in India with Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates.

    The company has its own Research & Development centre at Kandivli (west), Mumbai, state of the art, Bulk Drug Manufacturing (API) Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla with approval of MHRA (UK), MCC (SA) and other International Regulatory Authorities.

    Job Description / Responsibilities Knowledge of Regulatory requirement for different countries (For Regulated/ Non Regulated Market)

    10-20 year experience in Regulatory related work.
    Knowledge of latest guidelines of all countries.
    Responsible for Regulatory Dossier (ACTD or eCTD):
    o Module 1to 5
    Working with Operations for Publishing of the Dossier as per country requirements (eCTD/CTD/National Requirements).

    Chair of Labelling Subteam Meetings (LST) which includes Subject Matter Experts from Medical Affairs, Pharmacovigilance, Clinical Development and Nonclinical Development.

    Maintain awareness of changes to/new regulations affecting Pharmacovigilance activities.

    Knowledge of Preparation & compilation and reviewing the documents which is coming from manufacturing site for the preparation of dossiers for various countries along with legal documentations.

    Tender file Preparation, as per the bid documents.

    - -Knowledge of Regulatory requirements as per UKMHRA, MCC, TGA, USFDA, ANVISA ACTD guidelines.

    Should be able to handle team of regulatory.

    Should have hands of experience in QC/QA/Production Dept.

    Desired profile of the candidate B.Pharm / M.Pharm, B.Sc/M.Sc

    RUSAN PHARMA LTD.
    PLOT NO. 58 D, GOVT. INDUSTRIAL ESTATE, CHARKOP,
    KANDIVLI (WEST), MUMBAI 400 067.
    Email id hrmumbai@rusanpharma.com
    Website http://www.rusanpharma.com

Salary: Not Disclosed by Recruiter

Industry: Pharma / Biotech / Clinical Research

Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager

Keyskills

CTD QA Pharmacovigilance Medical Affairs USFDA Regulatory Affairs Team Handling

Desired Candidate Profile

Education-

UG: B.Pharma - Pharmacy

PG:M.Pharma - Pharmacy

Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required

    Please refer to the Job description above
Company Profile:

Rusan Pharma Ltd

Rusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. The company has its own Research & Development centre at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla having approval of MHRA (UK), MCC (SA) and other International Health Authorities. March 2008 - 82 Crs., Expected by March 2009 - 150 Crs.
Previous Page Next Page

People Searching On This Page:
  • rushan farma ankleswar
  • rusan pharma foto dehradun
  • rusan company image
  • rusan pharma plant in gujrat
  • Job vacancies
  • rusan images
  • lupin pharma jobs for freshers
  • rushan farma gandhidham
  • rusan pharma
  • rusan pharma Gujarat plant photos
  • Approval of regulatory body of rusan pharma dehradun unit

Related Pages


BSC/ MSC/ B.Pharma/ M.Pharma Jobs as Quality Assurance Jobs in Sun Pharma

BSC/ MSC/ B.Pharma/ M.Pharma Jobs as Quality Assurance Jobs in Sun Pharma

Jobs | Quality Assurance
Date:
21-Dec-2016  Views: 53655

Sun Pharma ranks amongst India's largest pharma companies We’ve built a reputation for speciality therapy leadership and faster- than-industry growth ...
Regulatory Affairs Jobs with Leading Pharmaceutical Company

Regulatory Affairs Jobs with Leading Pharmaceutical Company

Jobs | Regulatory Affair | Gujarat
Date:
31-May-2015  Views: 4649

It is a leading Active Pharmaceuticals Ingredients (API) Manufacturing Company in India. Company were started in 2006 and is headquartered at Surat, G ...
Regulatory Affairs Jobs in Sun Pharmaceutical Ltd

Regulatory Affairs Jobs in Sun Pharmaceutical Ltd

Jobs | Regulatory Affair | Mumbai
Date:
30-Mar-2015  Views: 7838

Sun Pharma an international,specialty pharmaceutical company headquartered in India with a global manufacturing network across 25 countries. We manufa ...
Pharma QA,QC,Production,Regulatory,Packaging Jobs in Amneal Pharma

Pharma QA,QC,Production,Regulatory,Packaging Jobs in Amneal Pharma

Jobs
Date:
24-Jan-2015  Views: 9657

Jobs Opening for below various Pharmaceutical Field for B.Pharma, M.Pharma, B.S.C. , M.S.C.QC MicroQA - QMS Injectable (Vial / Lyophilisation )QA - Va ...
Regulatory Affairs Jobs Pharma (API) in Cadila Healthcare Limited

Regulatory Affairs Jobs Pharma (API) in Cadila Healthcare Limited

Jobs | Regulatory Affair | Gujarat
Date:
25-Dec-2014  Views: 4342

Zydus Cadila is an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products. T ...
Post Your Comments (No Login Require)
Name : (required)
Email : (required)
Website :

Comment : (required)

45  + 6 =     
Comments
People Searched About:
Rushan Farma Ankleswar   |   Rusan Pharma Foto Dehradun   |   Rusan Company Image   |   Rusan Pharma Plant In Gujrat   |   Job Vacancies   |   Rusan Images   |   Lupin Pharma Jobs For Freshers   |  
Google : 333 times | Yahoo : 9 times | Bing : 104 times |