Regulatory Project and Resource Manager

3 tygodni temu

Warszawa, Mazovia, Polska GSK Pełny etat

GSK is seeking a dedicated Regulatory Project and Data Manager (RPDM) to join our team. The RPDM will work closely with Regulatory Matrix Teams and Early/Medicine Development Teams to provide planning support and resource management for Rx and Vx projects from Commit to Candidate (C2C) through post-approval R&D activities.

Key Responsibilities:

  • Independently deliver high-quality integrated Regulatory Development Plans (RDPs) based on input from Global Regulatory Leads (GRLs) and project teams, adhering to GSK and IRM plan quality and process expectations, industry and regulatory standards.

  • Maintain the integrated Regulatory Development Plan (RDP) to operationalize the Global Regulatory Strategy, ensuring accurate capture of regulatory deliverables, timelines, and resource needs for each phase of development.

  • Provide Regulatory functional line planning support for multiple projects from Commit to Candidate (C2C) through post-approval R&D activities.

  • Manage work packages within the RDP to reflect necessary Regulatory deliverables and agreed Global Regulatory Strategy, ensuring accurate development strategies through the management of work packages and associated logic.

  • Collaborate with other functional plan owners and project managers to ensure awareness of regulatory deliverables and alignment across all plan types within a project group.

  • Support R&D Governance reviews, including Development Review Board (DRB) and Portfolio Investment Board (PIB), ensuring complete, accurate, and purpose-fit data for informing business decisions.

Why you?Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor's degree in a biological, healthcare, or scientific discipline.

  • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.

  • Project management experience, preferably in the pharmaceutical industry or a regulatory environment.

  • Strong project management skills and ability to work with stakeholders spanning multiple functional areas.

  • Experience with project management principles and systems (e.g., Planisware) and resource management and reporting features (e.g., Spotfire).

  • Excellent written and verbal communication skills with the ability to present information clearly and concisely.

  • Ability to work independently and within a matrix environment, ensuring on-time delivery of objectives with minimal supervision.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Strong sense of urgency and ability to effectively prioritize tasks to ensure timely and effective handling of key issues and matters.

  • Demonstrated experience in essential skills such as data analysis, problem resolution, and the use of enterprise-wide project management tools.

  • Ability to present data and visualizations based on the needs of the target audience.

  • Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.

Why GSK?

What we offer:

  • Career with purpose - whatever it is you're doing, you'll be sharing our mission to improve the quality of human life, by enabling people to do more, feel better and live longer.

  • Non-wage benefits (medical care, life insurance, pension scheme, sports card, recreation allowance, social fund, preventive healthcare services).

  • Hybrid working model (2/3 days per week in the office).

  • Career at one of the leading global healthcare companies.

  • Supportive & friendly working environment.

  • Corporate culture, based on being Ambitious for patients, Accountable for Impact and Doing the right thing, which powers our purpose, drives delivery of our strategy and helps make GSK a place where people can thrive.

Inclusion at GSK:
Inclusion at GSK is key for our success.

If you need any adjustments in the recruitment process due to health reasons, please get in touch with our Recruitment Team (pl.recruitment-adjustments@gsk.com) to further discuss this today.

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