Freyr Solutions · 16 hours ago
Senior Project Manager - Regulatory Affairs
United States
Full-time
Remote
Senior Level, Lead/Staff
12+ years exp
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Hiring Manager
Syed A.
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Responsibilities
Partners with GRL on GRTs to ensure global regulatory project plans for programs are established and maintained; plans & directs the seamless execution of the GRT goals.
Expertly leads cross functional submission working groups (SWG) to deliver successful submissions/filings and outcomes to Health Authorities by providing expert and effective Project Management leadership, oversight, direction and planning.
Directly supports GRL by providing regulatory operational support for the asset, performs regulatory operational activities for assigned programs, when required
Partnering with the program GRL to co-lead and facilitate GRT meetings and cross-functional submission working groups (SWG) meetings - oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy of the program.
Develop and maintain integrated regulatory project plans and SWG time-lines and plans.
Provide and oversee regulatory operational support activities for assigned programs, operational support may include, but not limited to drafting and preparation of forms and cover letters, providing logistical support for health authority meetings, coordinating briefing book/response document roundtables, drafting regulatory notifications, coordinating and managing regulatory document workflows, inputting information into regulatory information management systems, preparing, checking and tracking regulatory data and lists etc.
Prepare and deliver reports and metrics on major regulatory milestone status, collaborate with the GRL in presenting operational strategies and plan statuses to key stakeholders (e.g. GPT members, Regulatory Leadership. TAUs & BUs) as appropriate
Identify and propose solutions for addressing potential systemic bottlenecks and constraints.
Elevate high impact business critical issues and potential critical issues together with proposed plan of action, as appropriate, in a timely manner to GRL and management.
Qualification
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Required
Experience: 12+ years
Partners with GRL on GRTs to ensure global regulatory project plans for programs are established and maintained; plans & directs the seamless execution of the GRT goals.
Expertly leads cross functional submission working groups (SWG) to deliver successful submissions/filings and outcomes to Health Authorities by providing expert and effective Project Management leadership, oversight, direction and planning.
Directly supports GRL by providing regulatory operational support for the asset, performs regulatory operational activities for assigned programs, when required
Partnering with the program GRL to co-lead and facilitate GRT meetings and cross-functional submission working groups (SWG) meetings - oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy of the program.
Develop and maintain integrated regulatory project plans and SWG time-lines and plans.
Provide and oversee regulatory operational support activities for assigned programs, operational support may include, but not limited to drafting and preparation of forms and cover letters, providing logistical support for health authority meetings, coordinating briefing book/response document roundtables, drafting regulatory notifications, coordinating and managing regulatory document workflows, inputting information into regulatory information management systems, preparing, checking and tracking regulatory data and lists etc.
Prepare and deliver reports and metrics on major regulatory milestone status, collaborate with the GRL in presenting operational strategies and plan statuses to key stakeholders (e.g. GPT members, Regulatory Leadership. TAUs & BUs) as appropriate
Identify and propose solutions for addressing potential systemic bottlenecks and constraints.
Elevate high impact business critical issues and potential critical issues together with proposed plan of action, as appropriate, in a timely manner to GRL and management.
The ideal candidate preferably has 8+ yrs experience in regulatory affairs or regulatory project management.
Expertise with project management related software and tools e.g. MS Project, OnePager, Office Timeline, SharePoint, OneNote required.
Proven ability to provide regulatory operational support with eCTD and non eCTD submissions – experience with working in EDMS system, solid understanding of eCTD structure required.
Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process required.
At least one major (original or supplement) and several minor (amendment) filing experience in one or more jurisdictions, along with eCTD experience is required – experience developing and managing submission time-lines required.
Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support.
Good verbal and written communication skills and ability to prepare effective presentations with focused messaging.
Demonstrates strong ability to work collaboratively and interact with other departments as well as external organizations.
Company
Freyr Solutions
Freyr is a Global, Regulatory-focused solutions and services company for Life Sciences Companies supporting, Large, Medium, and Small firms.
1,001-5,000 employees
Funding
Current Stage
Late StageLeadership Team
Rajiv Rangan
Co-Founder, Co - CEO | Innovation Evangelist
Srini Sadhu
Co-Founder
Recent News
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