Instagram
youtube
Facebook

Regulatory Affairs Associate (Chennai/Indore)

0-3 years
Not Disclosed
12 June 10, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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 Description Summary:

The person will be responsible for the compilation/review of supplements (including Injectable and OSD dosage form), Global Annual Reports, and preparation of summary documents for regulatory submission.

Job Description:

  • Prepare, review, and submit amendments and supplements for the assigned products.
  • Prepare summary documents for regulatory submission.
  • Prepare, review, and submit responses to the Agency’s queries for the assigned products.
  • Compile and submit Global Annual Reports.
  • Review stability protocols and reports, analytical method validation protocols, and reports.
  • Review raw material, packaging material, finished product specifications, finished product stability specifications, and testing procedures.
  • Review batch records.
  • Review Process Validation Protocol, hold time study protocols, and reports.
  • Review Product Development Report.
  • Review executed documents, including executed BMR, Certificate of Analysis, to ensure compliance with regulatory requirements.

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating and valuing each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.