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    Sr. Manager, Regulatory Asset Oversight

    Gsk Plc
    15-21 years
    Not Disclosed
    Bangalore
    10 Dec. 19, 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 Title: Manager, Regulatory Asset Oversight
    Location: Bengaluru Luxor North Tower, Bengaluru
    Posted Date: Dec 13, 2024
    Experience: 16-21 years

    Job Purpose:
    The Manager, Regulatory Asset Oversight, will drive regulatory transformation and ensure successful outcomes for GSK by managing multiple projects and teams. This role involves overseeing the regulatory lifecycle, managing risk assessments, and improving regulatory processes, policies, and systems. The Manager will play a key role in supporting global regulatory strategies, facilitating regulatory submission deliveries, and enhancing operational efficiencies across teams.

    Key Responsibilities:

    • Global Regulatory Strategy Support: Work closely with the Global Regulatory Lead (GRL) and Regulatory Management Teams (RMT) to develop and maintain a holistic view of the global regulatory plan. Support the execution of regulatory strategies and ensure the appropriate resources are engaged to deliver according to the Global Regulatory Strategy (GRS).
    • Submission Strategy & Risk Management: Lead the development of submission delivery strategies aligned with R&D objectives, including the implementation of acceleration strategies in various regions. Perform scenario planning and impact analysis, ensuring risks are identified and mitigated.
    • Cross-Functional Collaboration: Act as a single point of contact with RMTs, submission coordination, and publishing teams to identify and remove obstacles that may hinder submission success.
    • Regulatory Meeting & Governance Support: Facilitate and drive success in RMT meetings and cross-functional engagements, ensuring all logistics, agenda topics, and materials are well-prepared.
    • Submission Monitoring & Performance Metrics: Promote the use of integrated regulatory technologies to provide real-time submission status updates, maintaining meaningful metrics to assess team performance and compliance.
    • Governance Review Support: Assist the GRL in preparing governance reviews, leveraging data from RIM systems and ensuring accuracy, completeness, and suitability for submission processes.

    Education and Experience Requirements:

    • Basic Qualifications: Bachelor’s Degree with extensive knowledge of drug development, manufacturing, and regulatory requirements. Proven ability to manage multiple projects and teams in a global environment.
    • Preferred Qualifications: Degree in Chemistry, Pharmacy, or a closely related science. Demonstrated growth in global regulatory affairs, with experience in influencing and negotiating with internal and external stakeholders. Previous line management experience is a plus.

    Why GSK?
    GSK is a global biopharma company committed to advancing science and technology to address global health challenges. We focus on four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology. At GSK, we foster a culture of innovation, performance, and inclusion, providing opportunities for growth and a positive impact on the world’s health.

    Important Notice:
    GSK does not accept referrals from employment agencies without prior written authorization. We do not charge any fees for recruitment. Be cautious of fraudulent job postings and unsolicited emails. Always verify job offers by contacting us at askus@gsk.com.

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