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    Senior Director, Global Regulatory Portfolio Lead

    Sun Pharma
    15+ 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 Director, Global Regulatory Portfolio Leader
    Location: East Coast, with intermittent travel to New Jersey (Princeton)
    Company: Sun Pharmaceutical Industries Ltd.

    Position Overview

    The Senior Director, Global Regulatory Portfolio Leader will lead regulatory strategy for in-line and pipeline assets across multiple therapeutic areas. This leadership role will ensure the development and implementation of efficient global registration pathways to secure approvals and maintain product licenses in various geographies. This position is part of the Global Regulatory Affairs Leadership Team (GRA LT) and will report directly to the VP/Head, Global Regulatory Affairs.

    Key Responsibilities

    Regulatory Leadership

    • Serve as the key corporate regulatory contact for US and other markets, potentially acting as a US Agent for one or more assets.
    • Lead and manage a team of US and/or global regulatory leaders (as assigned).
    • Provide strategic, tactical, and operational guidance for pipeline products and key regulatory milestones.
    • Develop, execute, and maintain regulatory commitments and requirements for assigned programs.

    Regulatory Strategy & Communication

    • Stay informed on regulatory agency regulations, directives, and guidelines to assess approval pathways and potential issues impacting product development.
    • Lead communication with regulatory agencies (FDA, EMA, etc.), ensuring clear and documented interactions.
    • Set and monitor submission timelines in collaboration with key stakeholders.
    • Facilitate and oversee regulatory submissions, ensuring they meet all requirements for successful approval.
    • Ensure documentation of all communications with regulatory agencies and distribute to relevant teams.

    Team Development & Training

    • Develop and manage a high-performing team, providing coaching, delegation, and resource allocation.
    • Conduct training sessions to educate the regulatory affairs team on policies and procedures.
    • Review and contribute to the development of departmental procedures and best practices.

    External Relationships

    • Build and manage relationships with regulatory agencies, industry groups, and business partners.
    • Review audit reports and regulatory inspection reports and oversee responses as needed.
    • Monitor and evaluate regulatory activities to ensure compliance and smooth product development.

    Qualifications

    Education & Experience

    • Advanced degree (MD, PhD, PharmD, JD, MS, MBA) preferred.
    • 15+ years of experience in global regulatory leadership, with a proven track record of achieving regulatory milestones (e.g., approvals, expedited program designations).
    • Extensive experience with regulatory disciplines, including global/regional strategy, clinical, nonclinical, and CMC.
    • Experience in authoring and filing regulatory documents for major regulated markets.

    Leadership & Skills

    • Strong organizational and leadership abilities, with demonstrated experience in team building and staff development.
    • Ability to prioritize tasks and allocate resources efficiently within a nimble resourcing environment.
    • Expertise in managing regulatory submissions and working with regulatory bodies such as FDA and EMA.
    • Exceptional communication skills and the ability to influence and collaborate across global teams.

    Benefits & Compensation

    • Annual Performance Bonus Plan and eligibility for the Long-Term Incentive Plan.
    • Comprehensive employee benefits package, including medical, dental, and vision coverage, 401(k) savings plan, life insurance, disability benefits, and paid time off.
    • Flexible spending accounts, wellness programs, and employee assistance programs.

    How to Apply

    Interested candidates should apply directly to Sun Pharmaceutical Industries Ltd.

    Sun Pharmaceuticals is an equal opportunity employer. We do not discriminate based on race, religion, gender, sexual orientation, disability, or other protected categories.

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