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Regulatory Affairs Associate (Chennai/Indore)

2+ years
Not Disclosed
100 Dec. 25, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 Description: Regulatory Affairs Specialist

Summary

The Regulatory Affairs Specialist will be responsible for the compilation, review, and submission of supplements and amendments for both Injectable and Oral Solid Dosage (OSD) forms. This role involves preparing global annual reports and summary documents for regulatory submissions while ensuring compliance with all applicable regulatory requirements.


Key Responsibilities

  • Regulatory Submissions:

    • Prepare, review, and submit amendments and supplements for assigned products.
    • Develop and submit response documents addressing agency queries.
    • Prepare and compile summary documents for regulatory submissions.
  • Global Reporting:

    • Compile and submit Global Annual Reports for assigned products.
  • Document and Protocol Reviews:

    • Review stability protocols and reports, as well as analytical method validation protocols and reports.
    • Assess raw material, packaging material, and finished product specifications, including stability testing procedures.
    • Review batch records, process validation protocols, hold time study protocols, and reports.
  • Product Development:

    • Review Product Development Reports to ensure adherence to regulatory requirements.
  • Compliance Checks:

    • Evaluate executed documents, including executed Batch Manufacturing Records (BMR) and Certificates of Analysis (CoA), for compliance with regulatory standards.

Qualifications and Skills

  • Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related field.
  • Experience in regulatory affairs within the pharmaceutical industry, specifically with injectable and OSD dosage forms.
  • Strong knowledge of regulatory submission requirements and guidelines.
  • Familiarity with stability studies, analytical method validation, and process validation documentation.
  • Attention to detail and ability to review complex technical documents accurately.
  • Excellent communication skills, both written and verbal.

Commitment to Diversity, Equity, and Inclusion

At Endo, we believe diversity unites and empowers us as One Team. We are committed to fostering an inclusive culture where every unique perspective is valued and celebrated. Our team represents diverse backgrounds, experiences, and talents, and together we drive innovation and excellence.


About Us

Endo is on a mission to develop life-enhancing products through focused execution. With over 3,000 team members globally, we are dedicated to delivering healthcare solutions and supporting one another in bringing the best treatments forward.

Be the change you wish to see—join us at Endo!

For more information, visit our website and explore how you can contribute to a brighter future in healthcare.