Regulatory Affairs Officer Sr Officer
Regulatory Affairs Officer Sr Officer
Posted on :
20-01-2025
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1 Vacancy
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Job Description
Job Title: Regulatory Affairs Officer / Sr. Officer
Job Location: Ahmedabad Gujarat India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Skills:
ROW Market Prepare Dossiers Guideline Knowledge BE Report AMV BMRBPR
Company Overview
BioMatrix Healthcare Private Limited a leading exportoriented pharmaceutical company is headquartered in Ahmedabad Gujarat India. Established in 2007 we are committed to "Supporting Life Worldwide" through our cuttingedge R&D and manufacturing processes. Accredited by WHOGMP 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 Overview
BioMatrix Healthcare is seeking a motivated Regulatory Affairs Officer/Senior Officer to join our team in Ahmedabad. This fulltime midlevel 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 Skills
M.Pharm / B.Pharm
Sindhubhavan Road Thaltej Ahmedabad.
Roles And Responsibilities
Prepare 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 per
requirement
Review 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.
ROW Market Prepare Dossiers Guideline Knowledge BE Report AMV BMRBPR
Company Overview
BioMatrix Healthcare Private Limited a leading exportoriented pharmaceutical company is headquartered in Ahmedabad Gujarat India. Established in 2007 we are committed to "Supporting Life Worldwide" through our cuttingedge R&D and manufacturing processes. Accredited by WHOGMP 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 Overview
BioMatrix Healthcare is seeking a motivated Regulatory Affairs Officer/Senior Officer to join our team in Ahmedabad. This fulltime midlevel 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 Skills
M.Pharm / B.Pharm
- Proficient in ROW Market with strong understanding of market specifics and regulatory requirements (Mandatory skill).
Sindhubhavan Road Thaltej Ahmedabad.
Roles And Responsibilities
Prepare 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 per
requirement
Review 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.
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Employment Type
Full Time
Key Skills
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