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Regulatory Project Manager- Remote

Location: Gaithersburg, Maryland, United States
Job # 11822071
Date Posted: 01-10-2019
Regulatory Project Manager
Remote Opportunity

Our client is a growing, dynamic Fortune 100 company focused on developing inhalation combination therapies for the treatment of highly prevalent chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD) and asthma.  We are seeking a Regulatory Project Manager to be responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. 

• 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. 
• Lead and / or contribute to the planning, preparation 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 where relevant. 
• Provide coaching, mentoring and knowledge sharing within the RPM skill group. 
• Contribute to process improvement. 

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 
• Thorough knowledge of the drug development process 
• Knowledge of AZ Business and processes 

Skills and Capabilities 
• Excellent written and verbal communication skills 
• Cultural awareness 
• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions 
• Proficiency with common project management (e.g., MS Project) and document management tools 
• 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 
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