Regulatory Project Manager II

• The RPM will provide business support to Global Regulatory Affairs

• This individual will assist Global Regulatory Teams/Global Regulatory Leaders (GRT’s/GRLs) in determining resource requirements utilizing scheduling and resource management tools to support drug development teams without a dedicated RPM in R&D. Creates project and portfolio level reports utilizing various systems to support decision making for GRA, GRTs, PMO and TA management

• The RPM will provide GRT support

• This individual will translate the regulatory strategy into realistic and executable regulatory deliverables with clear assumptions based on GRT input

• The incumbent will work in close collaboration with the GRL to proactively prepare regulatory activities to be discussed in the GRT and will also work in close collaboration with the Regulatory Liaisons and Scientists to work out NA-EMEA-APJLA specific details on Health Authority interactions and submissions

• He/she will work in close collaboration with Submission Operations on pre-submission activities and will provide cross-functional leadership to the submission teams including direct management of Modules 1 and 2.

• The RPM will plan regulatory scenarios to support decision making in line with Regulatory and CDT strategy and supports early risk identification and development of mitigation strategies

• The RPM will manage the regulatory end-to-end process from entry into late development through launch and will proactively plan and manage the cross-functional project deliverables that support the global regulatory strategy and worldwide submissions (NA – EMEA - APJLA)

• Responsibilities will include: active follow-up on the progression of all regulatory activities required for successful and timely completion of the regulatory deliverables, monitoring regulatory driven key milestones, decision points and critical path activities, creation of project related reports to support decision making at the PMT, GRT and CDT level, regulatory portfolio oversight, support of team member planning of short and long term deliverables and informing stakeholders on project deliverables status

• The RPM is the single Point of Contact for “Regulatory Program Management” Activities

• The RPM will be responsible for the creation, maintenance, management and timely submission of regulatory project budgets (OOPs & FTEs)

• The RPM owns the Global Regulatory Affairs (GRA) schedule in P6; creation, monitoring and maintenance

• The RPM will liaise with the GRA Functions to insure alignment between CDT and GRA plans and SPS Regulatory plans

• This individual will represent “Regulatory Program Management” at the PMT and will work in close collaboration with the CDT PML and other PMT members to ensure alignment of the regulatory strategy with the CDT strategy and alignment of functional strategies with the regulatory strategy

• The individual will proactively manage the regulatory development plan (scope, time, and cost) and is the single Point of Contact for “Regulatory Program Management” activities.

• B.S. or advanced degree in pharmaceutical-related subject. Professional project management certification is a plus

• 5 years of relevant experience including at least 3-5 years in (bio) pharmaceutical R&D

• Experience in regulatory matrix organization is preferred

• Project management experience in R&D drug development is preferred; Registration experience with global submissions or preparation of dossiers is preferred

• Understanding of Regulatory processes, both pre- and post-marketing

• Knowledge of regulations, guidelines and regulatory requirements is preferred

• Detailed knowledge of: project planning, tracking, resource management, project planning and scheduling tools and cross-project analyses is preferred

• Versed in SharePoint, Planisware, Visio, and Tableau software packages is preferred

Thanks

Warm Regards

Ricky

732-429-1925