Regulatory Affairs Officer / Sr. Officer

Year    Ahmedabad, Gujarat, India
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Job Description


Job Title: Regulatory Affairs Officer / Sr. OfficerJob Location: Ahmedabad, Gujarat, IndiaJob Location Type: On-siteJob Contract Type: Full-timeJob Seniority Level: Mid-Senior levelSkills:
ROW Market, Prepare Dossiers, Guideline Knowledge, BE Report, AMV, BMR-BPR,Company OverviewBioMatrix Healthcare Private Limited, a leading export-oriented pharmaceutical company, is headquartered in Ahmedabad, Gujarat, India. Established in 2007, we are committed to "Supporting Life Worldwide" through our cutting-edge R&D and manufacturing processes. Accredited by WHO-GMP, we have a robust presence in over 30 countries, focusing on oral solids, liquids, and dry syrups. With over 850 product registrations, we are expanding our footprint in Europe, Latin America, and Southeast Asia.Job OverviewBioMatrix Healthcare is seeking a motivated Regulatory Affairs Officer/Senior Officer to join our team in Ahmedabad. This full-time, mid-level position requires a minimum of one year of experience and is pivotal in ensuring the compliance and registration of our pharmaceutical products. The successful candidate will play a key role in our regulatory submissions and expansion efforts within the ROW Market and beyond.Qualifications And SkillsM.Pharm / B.Pharm

  • Proficient in ROW Market with strong understanding of market specifics and regulatory requirements (Mandatory skill).
Job LocationSindhubhavan Road, Thaltej, Ahmedabad.Roles And ResponsibilitiesPrepare Dossiers for different countries.Evaluation, Verification & Proper Checking of DMF (Drug Master File) of API, &Checking of Bioequivalence Study Report (BE Report), Analytical Method Validation (AMV)Technical documents review.Checking of leaflets.Prepare Documents for queries of individual countries.Checking of Documents for COPP, Product Permission, LL Application as perrequirementReview of technical documents like BMR, BPR, Specifications, Label claim etc for the different dosage forms.Preparation of Leaflets.Check Samples against Registration Documents for Physical Parameters.Prepare & review Documents for queries of individual countries.Review Documents before compilation of Dossiers.Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.For more details and to find similar roles, please check out the below Lifelancer link.

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Job Detail

  • Job Id
    JD3599228
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Ahmedabad, Gujarat, India
  • Education
    Not mentioned
  • Experience
    Year
 
 
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