Regulatory Program Strategy Manager

• Will provide project management support for the regulatory end-to-end process from entry into late development through launch.
• Will represent “Regulatory Program Management” at the GRT.
• Translate regulatory strategy into realistic and executable regulatory deliverables with clear assumptions based on GRT input through leveraging of the Regulatory Strategy Document and Risk Registry
• Works out regulatory scenarios to support decision making in line with Regulatory and CDT strategy.
• Supports early risk identification and development of mitigation strategies.
• Works in close collaboration with the Regulatory Leader (GRL) to proactively prepare regulatory activities to be discussed in the GRT.
• Works in close collaboration with the Regulatory Liaisons and Professionals to work out NAEMEA-APJLA specific details on Health Authority interactions and submissions.
• Support Global filings across all regions; Initiate discussion, establish the Global filing plan and verify submission groups; maintain appropriate plans in the team Sharepoint site; ensure execution of the plans through discussion at the global and regional levels, assessing requirements and risks, monitoring progress and assessing critical path, and planning for submission roll out based on priorities.
• Works in close collaboration with Submission Operations for timing of pre-submission activities.
• Serves as single point of contact for “Regulatory Program Management” activities.
• Proactively plans and manages the cross-functional project deliverables that support the global regulatory strategy and worldwide submissions (NA – EMEA - APJLA).
• Active follow-up on the progression of all regulatory activities required to successfully and timely complete the regulatory deliverables (Health Authorities interactions, submissions, etc.).
• Monitors regulatory driven key milestones, decision points and critical path activities.
• Creates project related reports to support decision making at PMT, GRT and CDT level, supports regulatory portfolio oversight, supports team member planning of short- and long-term deliverables.
• Informs stakeholders on project deliverables status.
• Assists GRT’s in determining resource requirements utilizing scheduling and resource management tools to support early and late development teams, depending on TA and R&D needs.
• Coordinates the creation, maintenance, management and timely submission of regulatory project budgets (OOPs & FTEs).
• Owns the Regulatory tasks in the Planisware platform V6 program schedule; responsible for the creation, monitoring and maintenance.
• Owns the Regulatory schedule in MSPS16; responsible for the creation, monitoring and maintenance of the timelines. Depending on program plans this activity can start as early as Phase I Health Authority
• Interactions and extends through Initial Filings and into subsequent add-on submissions.
• Owns the Submission plan in MSP 16; creation, monitoring and maintenance.
• Creates visuals utilizing OnePager, OfficeTimeline, or Swimlane.
• Represents “Regulatory Program Management” at the PMT.
• Works in close collaboration with the CDT Program Management Leader (CDT-PML) to ensure alignment of the regulatory strategy with the CDT strategy.
• Works in close collaboration with the PMT Program Managers to ensure alignment of functional strategies with the regulatory strategy.
• Proactively manages the regulatory development plan (scope, time, cost).

• B.S. or advanced degree in pharmaceutical-related subjects. Professional project management certification is a plus. Regulatory Affairs Certificate 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.
• Regulatory experience in Pharmaceutical R&D with NDA/MAA submission experience is a must
• Project management experience in R&D drug development is a must.
• Detailed knowledge of: project planning, tracking, resource management, project planning and scheduling tools, and cross-project analyses.
• Registration experience with global submissions pre and post marketing is preferred.
• Understanding of Regulatory processes, both pre- and post-marketing.
• Working knowledge of regulations, guidelines and regulatory requirements is preferred; such as health authority requirements and Global CoPP needs.
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

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