Regulatory Associate Project Director

Job Description

Title : Regulatory Associate Project Director

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Location : Gaithersburg,Maryland

• The Associate Regulatory Project Director (ARPD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARPD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARPD provides regulatory expertise and guidance on procedural and documentation requirementsto GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Responsibilities :

• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including :
• Submission delivery strategy of all dossiers and all application types per market and / or region
• Review documents and provide regulatory input (e.g., response documents, high level documents, study protocols, PSRs, etc.)
• Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
• Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
• Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and / or regional perspective.
• Lead GRST & GRET sub-teams, i.e. Crossfunctional Submission Delivery teams for major submissions (NDA / MAA or major LCM initiative).
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Coordinate the input, maintenance and revision in the OPAL project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
• Identify regulatory risks and communicate mitigations to Lead RPM and cross functional teams.
• Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and / or alliance partners where relevant.
• May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
• Provide coaching, mentoring and knowledge sharing within the RPM skill group.
• Contribute to process improvement.
• When assigned Lead RPM role ARPD, responsibilities to include :
• Lead the GRET (Global Regulatory Execution Team).
• Overall accountability for the project management of all GRET deliverables.
• Key member of the Global Regulatory Strategy Team (GRST) with focus to deliver the GRST product plan submission milestones. This is achieved by development and execution of operationally efficient submission delivery plans by GRST and GRET members.
• Identify regulatory risks and risk mitigation strategies for GRET executions and deliverables (with input from all team members).
• Drive the GRST and GRET resourcing process.
• Supports Fee forecasting activities.
• AllocateRPM resources to the GRET deliverables.
• Liaise with GPM and other functional project managers.
• Knowledge sharing and RPM development; the go-to person for RPM project guidance and support, provides and facilitates coaching within / between the GRET and GRST.

Requirements :

• Relevant University Degree in Science or related discipline
• Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority.
• Thorough Knowledge of drug development
• Leadership skills, including experience leading multi-disciplinary project teams
• Managed first wave Marketing Application and / or LCM submissions
• Managed complex regulatory deliverables across projects / products
• Knowledge of AZ Business and processes
• Excellent written and verbal communication skills
• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
• Proficiency with common project management (e.g., MS Project) and document management
• Ability to work independently and as part of a team
• Influencing and stakeholder management skills
• Ability to analyze problems and recommend actions
• Continuous Improvement and knowledge sharing focused

Additional Information

All your information will be kept confidential according to EEO guidelines.

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