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Regulatory Project Manager

Company:
Artech Information Systems
Location:
Gaithersburg, Maryland, United States
Posted:
December 03, 2018

Description:

Job Description:

Job Title: Regulatory Project Manager

Location: Gaithersburg, MD

Duration: 12 Months

Responsibilities

The Regulatory Project Manager (RPM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RPM contributes to regulatory submission strategy, identifying submission risks and opportunities while leading simple through more complex regulatory applications and managing procedures through approval. The RPM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Accountabilities/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 input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:

o Submission delivery strategy of all dossiers and all application types per market and /or region.

o Review of documents (e.g. response documents, study protocols, PSRs, etc.).

o 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 simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.

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 propose mitigations to Lead RPM and cross functional teams.

Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners

Minimum Requirements –Education and Experience

Relevant University Degree in Science or related discipline

Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience

General knowledge of drug development. Strong project management skills

Leadership skills, including experience leading multi-disciplinary project teams

Preferred Experience

Regulatory experience

Managed regulatory deliverables at the project level

Knowledge of CLIENT’S Business and processes

Skills and Capabilities

Proficiency with common project management (e.g., MS Project) and document management tools

Continuous Improvement and knowledge sharing focused