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    Regulatory Affairs – Sr. Executive

    Amneal
    2+ years
    Not Disclosed
    Ahmedabad
    10 Sept. 25, 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, 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 Role: Senior Executive
    Department: Regulatory Affairs
    Location: Corporate Office, Ahmedabad

    Job Description:

    • Compile, prepare, review, and submit ANDA submissions and amendments to the FDA, aiming to minimize deficiencies and expedite approvals.
    • Maintain comprehensive awareness of all regulatory activities related to assigned projects, ensuring deadlines and performance standards are established and met.
    • Possess expertise and prior experience with OSD (Oral Solid Dosage) and sterile dosage forms (injectables, ophthalmic, otic, IV bags) for ANDAs.
    • Ensure timely submission of all assigned projects.
    • Review and prepare documents that meet US FDA requirements, ensuring they are accepted for review without queries or Refusal to Receive (RTR).
    • Evaluate change controls and develop strategies for appropriate filing categories with supervisor guidance, proactively reporting major project issues for resolution.
    • Compile and submit critical post-approval supplements, such as CBE, CBE-30, and PAS, as needed.
    • Collaborate closely with relevant departments during product initiation, R&D phases, ANDA/Bio execution, and stability initiation to ensure timely availability of submission documents.
    • Prepare and finalize controlled correspondence to the FDA on specific issues as required for assigned projects.
    • Assess deficiency letters from the FDA immediately upon receipt, perform detailed gap assessments, and discuss response strategies with supervisors.
    • Proactively raise significant project issues to superiors for resolution and agreement.
    • Maintain flexible work hours and be available for teleconferences with the US team as needed.
    • Evaluate final compositions for IIG (Innovator-Innovator Generic) and proportionality criteria, developing regulatory strategies to mitigate filing acceptability issues.
    • Thoroughly review API (Active Pharmaceutical Ingredient) Drug Master Files (DMFs) and provide timely feedback to the purchasing department. Follow up with the purchasing team or DMF holders to ensure compliance with comments.
    • Proofread and approve all OTC (Over-The-Counter) and Rx (Prescription) product labeling components.

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