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    Team Member, Regulatory Affairs

    Syngene
    6-13 years
    Not Disclosed
    Bangalore
    10 Jan. 28, 2025
    Job Description
    Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: Junior Manager - Regulatory Affairs
    Date: 21 Jan 2025
    Job Location: Syngene International Limited, Biocon SEZ, Biocon Park, Bommasandra Industrial Area, Bengaluru, Karnataka, India

    About Syngene

    Syngene International Ltd. is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services across the drug development lifecycle—from early discovery to commercial supply. Safety and quality are paramount in all operations at Syngene, with a focus on compliance with safety protocols and regulatory standards.

    Core Purpose of the Role

    The Junior Manager - Regulatory Affairs will provide expert regulatory guidance throughout the development cycle of novel and generic drug products (both small molecule and biologics). This role involves managing regulatory filings, lifecycle management, and post-approval activities for global markets, with a particular focus on developed countries. The candidate will lead eCTD filing, regulatory DMS, and QMS system activities.

    Key Responsibilities

    Regulatory Affairs & Filing:

    • Support CMC (Chemistry, Manufacturing, and Controls) regulatory activities across the development cycle, including marketing authorization and lifecycle management for small molecules and biologics.
    • Conduct regulatory research for new molecules and product categories, providing technical and feasibility inputs based on business needs.
    • Identify requirements for regulatory filings such as IND (Investigational New Drug), NDA (New Drug Application), MAA (Marketing Authorization Application), ANDA (Abbreviated New Drug Application), and ANADA (Abbreviated New Animal Drug Application).
    • Prepare checklists and ensure regulatory compliance for all required submissions.
    • Interact with stakeholders to collate necessary documents and review development, manufacturing, and regulatory documentation such as BMR (Batch Manufacturing Records), BPR (Batch Production Records), Specifications, Method Validation, and Process Validation reports.
    • Conduct regulatory assessments, identify risks, and recommend corrective measures to the team and clients.
    • Plan, develop, compile, and publish eCTD dossiers, ensuring timely submission to regulatory agencies.
    • Provide regulatory strategy inputs to internal teams and clients, assessing regulatory requirements for business needs.
    • Maintain regulatory filings, including product marketing authorization renewals, ensuring continuous validity.
    • Maintain and update product dossiers/DMFs as required, to ensure compliance with changes in internal systems and regulatory guidelines.

    Compliance & Quality Assurance:

    • Maintain and update the Quality Agreement Tracker and prepare Quality Agreement Checklists.
    • Train staff on regulatory policies and procedures, ensuring adherence to safety and regulatory standards.
    • Develop and maintain standard operating procedures (SOPs) or local working practices related to regulatory affairs.
    • Ensure compliance with environment, health, and safety (EHS) requirements at all times in the workplace.

    Leadership Capabilities

    • Decision-Making: Provide strategic regulatory input to the team and clients.
    • Guidance: Lead efforts in ensuring regulatory compliance and timely submission of filings.
    • Adherence to Timelines: Meet project deadlines and regulatory submission schedules.
    • Compliance: Uphold and drive regulatory compliance across all functions.

    Syngene Values

    • Excellence
    • Integrity
    • Professionalism

    Specific Requirements for this Role

    Experience:

    • 6 to 13 years of experience in CMC regulatory affairs for small molecule API/formulations (preferably in injectables) for markets like the US, Europe, and other developed countries.
    • Hands-on experience with investigational medicinal products and marketing authorization.
    • Experience with biologics, ADC (Antibody Drug Conjugates), or veterinary drugs is a plus.

    Skills and Capabilities:

    • High proficiency in reading, writing, and communicating in English.
    • Hands-on experience in eCTD filing.
    • Knowledge of RDMS (Regulatory Document Management Systems), EDMS (Electronic Document Management Systems), and QMS (Quality Management Systems) is a definite plus.
    • Thorough understanding of CMC (API & Drug Product) and regulatory interpretations.

    Education:

    • B.Pharm, M.Pharm, or a Life Sciences degree with a minimum of 5 years of experience in the pharmaceutical/life sciences industry.

    Equal Opportunity Employer

    Syngene is committed to providing equal employment opportunities to all persons, regardless of age, color, national origin, disability, race, religion, gender, sexual orientation, gender identity, or any other characteristic protected by law. Reasonable accommodations will be provided for qualified individuals with disabilities.

    For more details, visit www.syngeneintl.com.

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