What are the responsibilities and job description for the Regulatory Affairs Associate position at Pharbest Pharmaceuticals Inc.?
Primary responsibility is to compile, review, and submit various regulatory filings:
o *IND* (Investigational New Drug)
o *NDA/ANDA/BLA* (New Drug Application/Abbreviated New Drug Application/Biologics License Application)
o *DMF* (Drug Master File)
o Compile CTD/eCTD Modules*:
o Ensure submissions follow *country-specific regulatory guidelines* (FDA, EMA, MHRA, WHO, ICH).
o Monitor and interpret *changes in global regulations*, guidance documents, and standards.
o Ensure the company's processes align with:
o *FDA 21 CFR Parts 210/211, 820*, *ICH Q-series (Q1–Q14)*,*GMP/GLP/GCP*
o National regulatory frameworks (USFDA, EMA, CDSCO, TGA).
o Participate in *internal audits* to ensure compliance.
o R&D / Formulation Development* – for product data, specifications, formulation details.
· Quality Assurance (QA)
o For ensuring GMP compliance, SOPs, quality systems.
o Quality Control (QC)–
o To collect analytical method data, specifications, validation reports.
· Manufacturing
o For process validation, batch records, packaging configuration.
· Clinical & Pharmacovigilance
· When required, to support study filings or safety reporting.
· Review of Product Labeling and Promotional Materials
o Ensuring that labeling follows regulatory and legal requirements.
o Review **labels, cartons, inserts, leaflets (PIL/SmPC)*.
o Ensure promotional materials comply with:
o FDA labeling regulations, * OPDP guidance, * Local market requirements.,* Verify claims, dosage instructions, storage conditions, excipient declarations.
· Aerosol technology
o Particle engineering
o Dry powder inhalers (DPI), metered dose inhalers (MDI), and nebulizer formulations
o Device design and characterization
Deposition and absorption studies in lungs
o Dose–response relationship for inhaled drugs
o Toxicological evaluation of inhaled compounds
o Animal and human studies for pulmonary drug delivery
· Drug Discovery and Development
· Molecule Screening
o Involve in identifying and screening active pharmaceutical ingredients (APIs) or lead compounds with potential therapeutic effects.
· Formulation Development
o Develop and optimize formulations (tablets, capsules, injections, etc.) ensuring desired stability, efficacy, and patient compliance.
· Preclinical Research
o Conduct studies related to drug absorption, distribution, metabolism, excretion (ADME), and toxicity.
· Stability Studies:
- Perform accelerated and long-term stability studies according to ICH guidelines
Bachelor's Degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science.
Pay: $62,840.00 per year
Work Location: In person
Salary : $62,840