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Regulatory Affairs Manager III

Integrated Resources, Inc

Lower Gwynedd Township, Pennsylvania

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JOB DETAILS
JOB TYPE
Contractor
SKILLS
Administrative Skills, Business Plan, Business Practices, Business Processes, Clinical Trial, Conflict Resolution, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Experience, Drug Development, Due Diligence, Funding, GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GxP, Laptop PC, Leadership, Licensing, Matrix Management, Metrics, Negotiation Skills, People Management, Pharmacovigilance, Pre-Clinical, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Process Improvement, Project Planning, Project/Program Management, Quality Management, Regulations, Regulatory Compliance, Regulatory Submissions, Reporting Dashboards, Research & Development (R&D), Risk Analysis, Strategic Analysis, Systems Administration/Management, Team Player, Technical Writing, Training/Teaching Curriculum, Writing Skills
LOCATION
Lower Gwynedd Township, Pennsylvania
POSTED
1 day ago
Regulatory Affairs Manager IIIThe Manager, L&A Non-Portfolio Activities, is responsible for project management support for the BRQC Licensing & Acquisitions Group. This includes but not limited to: maintenance of the L&A Portfolio and Non-Portfolio Trackers; production of the monthly L&A Dashboard, preparation of all meeting agendas; project manage to completion the updating and re-versioning of L&A Procedures, Playbooks, Guidance Documents, etc.; supporting deviation/CAPA Management Processes for L&A Assessment Activities; supporting various administrative and operational aspects of BRQC 90/100 Day Assessment Plans (90/100DPs) for incoming opportunities as well as support/manage opportunities that fall outside the scope of typical L&A (funding opportunities, collaborations, etc.). Additional projects/tasks will also be supported, as needed. He/she will possess a quality mindset; have Quality Systems/Quality Management experience across GXPs (specifically desirable: adequate knowledge of GCP/clinical trial development; Pharmacovigilance principles and GLP/pre-clinical activities)Principal Responsibilities:Provide project management expertise and skills to all L&A activities and deliverables including metrics/dashboard updates and maintenance of the L&A Tracker and corresponding document libraries; provide guidance on tracking mechanisms & meeting structures.Support the 90/100 DP Process by creating and managing the Project Plans for select opportunities.Track and manage issues related to Due Diligence activities as applicable.Map and evaluate the Due Diligence (DD), 90/100 DP, Divestment and other applicable processes and provide recommendations as well as support the process for procedural revisions and the creation of new procedural documents as applicable.Consolidate checklists used across the L&A Team in support of DD, 90/100 DP and Divestments.Provide templates and or agendas for meetings governing BRQC L&A activities.Support additional BRQC Licensing and Acquisitions projects/tasks, as assigned. In addition, attendance/participation at applicable team meetings will be needed.Decision-Making and Problem-Solving: The Manager, L&A Non-Portfolio Activities, is a professional function that contributes to the cross functional BRQC and Enterprise L&A process, as supported by BRQC R&D. Decisions made and problems solved will involve: quality support strategy for projects in scope, working with various stakeholder groups both within BRQC and outside of BRQC, providing quality technical and content expertise to teams, reporting and summarizing to management.Reporting Relationships: The Manager, L&A Non-Portfolio Activities, is a contractor, functionally aligned to the Head of L&A within BRQC, or one of his/her delegates. The Manager, L&A Non-Portfolio Activities, is not an employee of client, but will use client equipment (e.g. laptop and network access) and will be assigned the BRQC – L&A training curriculum.Education: Bachelor's degree with minimum of 9 years' experience in a medium to large scale matrix organization which includes applicable compliance related field and/or equivalent time and experience in a related R&D area is required. Requires knowledge of the drug development process, good knowledge of worldwide GxP compliance regulations, sound research and development practices, scientific and quality terminology, and quality evaluation techniques.Related Experience: Ability to interpret data to develop action plans to improve business. Must have strong personal leadership with demonstrated competency interfacing with all levels of the organization including senior leaders; Strong networking and relationship building skills; Ability to create an open and inviting environment; Embraces generational differences; Exceptional written and verbal communications skills. Experience in R&D collaborative study requirements to successfully drive BRQC support, strategy and risk assessment. Ability to translate data into information and strategies into executable action plans. Ability to motivate professional colleagues and stakeholders. Conflict resolution/management and negotiation skills. Ability to independently plan, organize, coordinate, manage and execute assigned tasks. Experience of the key customers' business processes and practices; experience of the overall drug development process is an asset. Experience in quality activities, including compliance support and audits of regulatory submissions is an asset.

About the Company

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Integrated Resources, Inc