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Regulatory Affairs Officer / Sr. Officer

1-6 years
Not Disclosed
10 Jan. 15, 2025
Job Description
Job Type: Full Time Education: M.Pharm / B.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Officer / Sr. Officer
Location: Ahmedabad, India
Job Type: Full-Time, Mid-Level (1 to 6 years of experience)
Posted on: December 24, 2024

Company Overview:
BioMatrix Healthcare is a leading export-oriented pharmaceutical company, headquartered in Ahmedabad, Gujarat, India. Established in 2007, the company is committed to "Supporting Life Worldwide" through advanced R&D and manufacturing processes. Accredited by WHO-GMP, BioMatrix Healthcare is present in over 30 countries, with a focus on oral solids, liquids, and dry syrups. The company has over 850 product registrations and is expanding its footprint in Europe, Latin America, and Southeast Asia.

Job Overview:
BioMatrix Healthcare is seeking a motivated Regulatory Affairs Officer/Senior Officer to join the team in Ahmedabad. The role involves ensuring the compliance and registration of pharmaceutical products, focusing on regulatory submissions and expansion efforts within the ROW (Rest of the World) Market.

Roles and Responsibilities:

  • Prepare Dossiers for different countries.
  • Evaluate, verify, and check DMF (Drug Master File) of API and BE Report (Bioequivalence Study Report).
  • Review technical documents such as BMR, BPR, specifications, and label claims for different dosage forms.
  • Check leaflets and product samples against registration documents for physical parameters.
  • Prepare and review documents for individual countries’ queries, including COPP, product permission, and LL applications.
  • Prepare and review documents before compiling Dossiers.

Qualifications and Skills:

  • M.Pharm / B.Pharm
  • Proficient in ROW Market with a strong understanding of market-specific regulatory requirements.

Job Location:
Sindhubhavan Road, Thaltej, Ahmedabad, India.