Manager, Regulatory Asset Oversight

10-15 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: 10-15 years

Job Purpose:
The Manager, Regulatory Asset Oversight, will drive regulatory transformations and ensure the successful regulatory outcomes for GSK. In this role, you will manage multiple projects and teams, assessing metrics and providing data-driven conclusions and action plans. You will focus on identifying risks related to submission data and lead continuous improvement in regulatory processes, policies, and systems.

Key Responsibilities:

Global Regulatory Strategy Support: Collaborate with the Global Regulatory Lead (GRL) and Regulatory Management Teams (RMT) to develop and maintain a comprehensive view of the global regulatory integrated plan. Ensure resource allocation for operationalizing the Global Regulatory Strategy (GRS).
Submission Strategy & Risk Management: Drive execution of agreed plans to ensure timely delivery per the Global Regulatory Strategy, performing scenario planning and critical path analyses. Identify risks and facilitate their mitigation.
Cross-Functional Collaboration: Act as the Single Point of Contact for RMTs and Submission Delivery Excellence teams to address barriers preventing successful filing outcomes.
Regulatory Meeting Coordination: Organize and facilitate RMT meetings and other regulatory cross-functional engagements, ensuring smooth logistics, agenda topics, and well-organized materials.
Submission Monitoring & Performance Metrics: Use regulatory technologies to provide real-time, accurate submission status, highlighting compliance and tracking submissions from central dispatches through to market registrations.
Governance Review Support: Assist in data analysis from RIM systems for governance reviews, ensuring data is accurate and complete for submission purposes.
Lifecycle Filing Strategy: Ensure alignment of submission delivery strategies from lead markets to regional expansion by facilitating discussions with LOCs and RMTs.
Continuous Improvement: Provide Subject Matter Expertise (SME) in process improvements, automation opportunities, and compliance with regulatory authority requirements.

Education and Experience Requirements:

Basic Qualifications: Bachelor’s degree with in-depth knowledge of drug development, manufacturing, and regulatory requirements. Proven experience managing multiple projects in a global environment.
Preferred Qualifications: A degree in Chemistry, Pharmacy, or a related science. Demonstrated professional growth in global regulatory affairs, including staying updated on emerging trends and policies. Experience influencing and negotiating with both internal and external stakeholders.

Why GSK?
GSK is a global leader in biopharma, dedicated to improving global health through vaccines, medicines, and innovative treatments. Our values of patient focus, integrity, respect, and teamwork are at the core of our culture. GSK is a place for talented individuals to grow, contribute, and thrive, shaping a healthier future for all.

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

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Manager, Regulatory Asset Oversight

Job Description

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