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Sr. Manager, Regulatory Asset Oversight

16-21 years
Not Disclosed
10 Dec. 20, 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, Bangalore
Posted Date: Dec 13, 2024
Job ID: [Insert Job ID]

Company Overview:
GSK is a global biopharmaceutical company with a special purpose – to unite science, technology, and talent to get ahead of disease together. Our ambition is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns. We focus on the science of the immune system, utilizing new platform and data technologies, and invest in four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology. At GSK, we are committed to building a diverse and inclusive workplace where people can thrive and grow.

Position Overview:
The Manager, Regulatory Asset Oversight, will play a pivotal role in driving transformation efforts to enable successful regulatory outcomes for GSK. This position will manage multiple projects and teams simultaneously, providing assessments, conclusions, and action plans within and across departments. The Manager will lead initiatives to improve regulatory processes, policies, and systems, identifying risks and ensuring the successful execution of regulatory strategies.

Key Responsibilities:

  • Collaborate with the Global Regulatory Lead (GRL) and Regulatory Management Teams (RMT) to develop and maintain an integrated global regulatory plan for assets.
  • Ensure alignment and execution of the Global Regulatory Strategy (GRS) by driving critical path analyses, scenario planning, and risk mitigation.
  • Support the submission delivery strategies for both global and regional markets.
  • Lead cross-functional meetings, including RMT meetings and other regulatory engagements, ensuring the availability of materials and effective logistics.
  • Identify and resolve barriers to successful filing strategies and escalate issues as needed.
  • Promote and drive the use of integrated Regulatory technologies for real-time submission status tracking.
  • Support the GRL in preparing governance reviews, ensuring data accuracy and completeness.
  • Facilitate discussions with regional/local teams to ensure alignment on submission strategies.

Basic Qualifications:

  • Bachelor’s degree
  • Extensive knowledge of drug development, manufacturing, and supply processes
  • Broad understanding of global regulatory requirements
  • Proven experience managing multiple projects

Preferred Qualifications:

  • Degree in Chemistry, Pharmacy, or a closely related science
  • Experience in global regulatory affairs and influencing key stakeholders
  • Line management experience

Why GSK?
At GSK, our values of patient focus, transparency, respect, integrity, courage, accountability, development, and teamwork guide us in everything we do. We foster an environment of continuous learning, and our people are empowered to make a difference, both for our patients and for their personal growth. Join us at this exciting time in our journey to get ahead together.

Important Notice to Employment Businesses/Agencies:
GSK does not accept unsolicited referrals from employment businesses/agencies. For job inquiries, please contact GSK's commercial and general procurement/human resources department.

Why Join Us?
If you’re driven to make a positive impact, foster growth, and lead transformation in regulatory outcomes, we invite you to apply for the Manager, Regulatory Asset Oversight role at GSK.