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Regulatory Affairs Project Manager
Durham, NC 22703 United States
Pearl Therapeutics, a wholly-owned subsidiary of AstraZeneca, is a growing, dynamic company focused on developing inhalation combination therapies for the treatment of highly prevalent chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD) and asthma. Pearl is seeking to hire individuals that bring energy and passion to deliver the medicines that provide patients and healthcare provider’s therapies to achieve better clinical outcomes.
The Regulatory Affairs Project Manager (RPM) is responsible for planning, tracking and reporting metrics for global regulatory activities and submissions. The candidate will have project management experience in the pharmaceutical industry, ideally in a regulatory affairs group. The candidate will be extremely well organized, wield the ability to pay close attention to details, and effectively ensure regulatory activities are coordinated and communicated to meet agreed-upon timelines.
Duties and Responsibilities:
The 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 global regulatory teams and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
In this role you will be responsible for understanding the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions. You will provide regulatory input 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 of documents, and analysis of regulatory procedures and special designations used during development, authorizations and extension of the product. You will 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. In addition, you will be leading 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. You will develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders. You will coordinate the input, maintenance and revision to the project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner. You will identify regulatory risks and propose mitigations. You will also support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, submission of regulatory documents to the trial master file, and document management utilizing the support and input of regulatory operations, local country regulatory affairs experts, and external vendors where relevant. You will provide coaching, mentoring and knowledge sharing within the RPM skill group, and contribute to process improvement.
• Relevant University Degree in Science or related discipline, preferably with life sciences focus
• Minimum of 2-3 years of pharmaceutical industry experience and 1-3 years of regulatory affairs experience, 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
• 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
• May require travel of 10-15% of working time
North Carolina Biotechnology Center