Our passion for science and technology is what drives our around 63,000 employees in 65 countries to find solutions to some of today’s toughest challenges and create more sustainable ways to live. We are here for people at every step, helping to create, improve and prolong life. We deliver personalized treatments for serious diseases and enable people to achieve their dream of becoming parents. We empower the scientific community. Our tools, services and digital platform make research simpler, more exact, and help deliver breakthroughs more quickly. Our solutions accelerate access to health by assuring tests are accurate and the medicine we take can be trusted. We are the company behind the companies, advancing digital living. Our science sits inside technologies that are changing the way we access, store, process, and display information.
Post : Senior Specialist Regulatory Project Management Office
Job Description
The Regulatory Project Manager Officer will be a member of the GRA Portfolio Management Team to contribute to defining the annual strategic direct to evolve the impact of the function for the GRSTs / IRSTs and GRA functions (timelines, risks, priorities, direct costs, and FTE demand)
The position will be working in a matrix organization with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will have to enable the preparedness of the employees to work on different projects and roles, to facilitate communication within the matrix organization, to ensure efficient and scalable resourcing supporting the business priorities.
• Act as PMO for GRSTs and create, maintain, and evolve templates and tools used in the GRSTs.
• Close collaboration with RPMs and GRLs to ensure that templates and tools are appreciated in the GRSTs along the lifecycle of assets and allow quick access to relevant information in a harmonized fashion across the GRSTs.
• Consolidate GRST relevant information at portfolio level on a quarterly basis (GRA Healthcheck)
• Collaborate with Leaders in TA Onc and TA Finer to steer, review and evolve metrics and KPIs measured in the GRA Healthcheck to provide transparent overview.
• Generate insights from data and reports to provide recommendation for improvements and enable a learning organization.
• Perform the annual GRST survey to get insights on the perception of all Global Regulatory Strategy Team members on the impact and provide insights to GRSTs as well as leaders across the TAs, functions, and regions.
• Close collaboration with SPH and RQS Operations to define business questions and requirements for reports and analyses to allow generation of GRA insights. Be the iMAP steward for the GRA functions.
• Be a member of the RQS SME group for FTE demand forecasting.
• Close collaboration with the Strategic Sourcing and Planning team within RQS Operations
• Coordinate the FTE demand planning SME group for GRA functions (TA Onc, TA Finer, REG CMC, REG Intl., Labeling and GRASP).
• Orchestrate the monthly update of skill assignments in the HR system for GRA functions and perform needed updates for TA FINER and TA Onc.
• Collaborate with GRA functions to generate needed insights on scenarios having resource implications for the functions and skills.
• Requires in-depth knowledge and experience in own discipline and beyond to supplement formal knowledge in order to apply principles and concepts to own discipline in resolving issues as they arrive.
• Thorough understanding of the Regulatory, R&D, including process and technology solutions
• Knowledge in business administration is a plus
• Portfolio & Project Management experience
• Supports the RPMs to update the iMAP system for the quarterly direct cost planning exercise and allows consolidation of direct cost demand, allowing comparison with actual spending assigned to the GRA part of the PST budget.
Candidate Profile
Degree in a Life Science, Medical, PharmD, or related discipline (minimum MSc or equivalent degree); higher degree preferable (e.g., PhD in a scientific discipline). Advanced training in portfolio & project management experience-related disciplines will be a strong advantage.
Experience: 8–14 years of work experience in a pharmaceutical environment, competent authority, or academia/R&D experience related to the role. Minimum 6-8 years of regulatory affairs or regulatory project management office experience.
Additional Information
Experience : 5+ years
Qualification : Degree in a Life Science, Medical, PharmD
Industry Type : Pharma/ Healthcare/ Clinical research
Location : Bangalore, Karnataka
End Date : 30th January 2025
See All B.Pharm Alerts M.Pharm Alerts M.Sc Alerts Bangalore Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
.png)
