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Senior Executive Drug Regulatory Affairs (E.U + U.S Pharma Markets)

4 - 9 yrs
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5,00,000 - 7,50,000 P.A. Posted 6 days ago Job Applicants: 685 Job Views: 3000+

Job Description

 
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    One of our clients, a globally operating European pharmaceutical company that develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company employs more than 3,000 professionals in different countries have the following opening:-

    Sr.Executive / Executive / Sr.Officer - Regulatory Affairs

    Job Description and Responsibilities:-

    To be responsible for the Life Cycle Management of assigned products, preparation of pharmaceutical/quality part (all forms) of registration dossiers and variations/amendments/annual reports as applicable documents in CTD and eCTD format according to EU regulatory requirements.

    To write, check/review of documents as per regulatory requirements
    To publish with software submission documentation as per regulatory requirements
    To response to regulatory deficiencies letters according to EU and USA regulatory requirements.
    To support local in-licensing
    To collaborate with other departments/partners
    To maintain lists/documents/records
    To achieve his/her responsibilities within the agreed timescales
    To actively participate in the development of regulatory skills within the regulatory team by continuous up-dating.

    Primary Skills (essential)

    4 - 8 years' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines.

    Experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities and eCTD submissions will be an added advantage.

    Fluency in oral and written English
    Task oriented with learning attitude and Team work skills
    Familiarity with Microsoft Office

Salary: INR 5,00,000 - 7,50,000 P.A. All employee benefits & perks as applicable to pharma Mnc's, 5 day week

Industry: Pharma / Biotech / Clinical Research

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

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager

Employment Type: Permanent Job, Full Time

Keyskills

drug regulatory affairs executive regulatory affairs senior executive drug regulatory affairs regulatory affairs manager assistant manager regulatory affairs dossier registration for u.s & e.u markets ra executive for regulated markets

Desired Candidate Profile

    M.Pharm / B.Pharm / M.Sc / B.Sc Graduates with 3+ years experience in the drug regulatory affairs functions for the export of finished formulations to the EU / US markets. Must be a resident of Mumbai / Navi Mumbai /Thane

Education-

UG: B.Sc - Any Specialization, B.Pharma - Pharmacy, BAMS - Any Specialization, BHMS - Any Specialization, Other Graduate

PG:Any Postgraduate - Any Specialization

Company Profile:

S.M.College of Memory

European pharma MNC having offices & operations in more than 20 countries in Europe as well as in India and China. The manufacturing operations are in Europe. Outside Europe, the important markets include the United States, the Latin America, Middle East and North Africa as well as Asia Pacific. In R&D, this company has built an international network of best-in-class partners around its core therapy areas. Partnerships are also a key component of the company's supply chain.
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Job Posted by

molly Recruitment Consultant S.M.College of Memory Mumbai

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