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    Senior Manager, Regulatory Affairs

    Sun Pharma
    3-5 years
    Not Disclosed
    Princeton Junction
    10 Nov. 28, 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

    Position: Senior Manager, Regulatory Affairs
    Company: Sun Pharmaceutical Industries Ltd.

    About Us

    Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company globally, with over $4.5 billion in revenue and more than 40 manufacturing facilities. We provide high-quality, affordable medicines to healthcare professionals and patients across more than 100 countries. Our corporate philosophy, Sunology, embodies our core values of Humility, Integrity, Passion, and Innovation.

    Position Overview

    The Senior Manager, Regulatory Affairs will be responsible for overseeing global regulatory submission activities, including publishing, coordination, and ensuring compliance with current global filing requirements. This role involves collaboration with internal teams and external stakeholders, tracking submission progress, and ensuring regulatory documentation meets all required guidelines.

    Key Responsibilities

    Regulatory Submission Coordination

    • Coordinate and manage various global regulatory submission tasks for multiple programs/projects.
    • Ensure compliance with eCTD structure and global regulatory filing requirements.
    • Work closely with submission strategists and stakeholders to define and implement submission strategies.

    Document Quality Control and Publishing

    • Perform quality control (QC) on incoming and outgoing regulatory data and documents, ensuring adherence to eCTD publishing standards.
    • Review and ensure final submission documents are accurate, compliant, and ready for Health Authority submission.
    • Archive submissions, Health Authority correspondences, and related documents within the Regulatory Affairs systems.

    Tracking and Reporting

    • Track submission activities and maintain detailed records, including audit trails, submission statuses, and timelines.
    • Provide periodic reports and present monthly snapshots or yearly metrics related to submission progress and activities.

    Health Authority Commitment

    • Maintain and update the Health Authority Commitment tracker, ensuring all post-approval commitments (e.g., Annual Reports, DSURs, PSURs, etc.) are tracked and communicated to stakeholders.

    Process Improvement and Best Practices

    • Participate in process enhancements and the implementation of new tools/systems within the department.
    • Contribute to writing and revising procedures for submission activities.
    • Lead or support internal and cross-functional training sessions, meetings, and documentation reviews.

    Publishing and Archival

    • Undertake publishing activities for various submission types, including NDAs, INDs, MAAs, CTAs, and other regulatory documents (e.g., 510(k)s, Orphan applications).
    • Ensure that submissions meet Health Authority guidelines for publishing (bookmarking, hyperlinking, PDF compliance).

    Qualifications

    Education & Experience

    • Associate or Bachelor’s degree required.
    • 3-5 years of experience in Regulatory Affairs with a focus on publishing, eCTD submissions, and regulatory documentation.

    Skills & Knowledge

    • Expertise in eCTD publishing and related regulatory tools/systems.
    • Strong timeline management skills and the ability to prioritize submission tasks.
    • Effective spoken and written communication skills.
    • Ability to work in a cross-functional, cross-cultural environment and collaborate with diverse teams.

    Abilities

    • Flexibility and adaptability in a dynamic, fast-paced environment.
    • Strong attention to detail and quality control in publishing regulatory documents.

    Benefits & Perks

    • Hybrid work arrangement
    • Medical, Dental, Vision Benefits
    • Health Savings Account (HSA) & Flexible Spending Account (FSA)
    • Prescription Drug Coverage
    • Telehealth & Behavioral Health Services
    • Income Protection – Short Term and Long Term Disability Benefits
    • Retirement Benefits – 401(k) with Company Match (100% vesting on Day 1)
    • Group Life Insurance
    • Wellness Programs
    • Corporate Discounts on cellular phones, entertainment, and consumer goods.

    About Sun Pharma

    At Sun Pharma, we are committed to making good health accessible and affordable to local communities worldwide. Through active research, fieldwork, and dedicated teams, we strive to help people live healthier lives.

    Sunology reflects our core values of Humility, Integrity, Passion, and Innovation, shaping our work culture and interactions with stakeholders.

    Apply Today!

    If you’re looking for a challenging and rewarding career in regulatory affairs, join our global team at Sun Pharma!

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