Senior Manager, Regulatory Affairs Submission Management

12 Nov, 2020

Jobs

Senior Manager, Regulatory Affairs Submission Management

Reata Pharmaceuticals
Remote (TX)

Job Details
Description
Primary responsibilities are the facilitation of Reata’s internal regulatory activities. The incumbent will provide project management capabilities to the Reata’s Regulatory Department to ensure the successful delivery of regulatory projects and milestones for drug development or marketed programs. This position will help develop Regulatory Plans that define the workflow and timeline of regulatory submissions, facilitate communication and alignment between regulatory functions, support tracking and reporting of RA metrics, and maintain global health authority commitment and response trackers.

RESPONSIBILITIES:

Partner with Global Regulatory Leads, Director CMC, and the Sr. Director, Regulatory Operations to ensure a seamless interface between these sub functions and facilitate effective communication within the Regulatory Affairs department
Working closely with the regulatory leads, develops regulatory submission plans and timelines and coordinates their execution with relevant regulatory functions, including Regulatory Operations
Partners with Program Management to ensure submission deliverables are incorporated and visible to all stakeholders
Ensures hand offs and deliverables from vendor authoring community are on time and in line with the submission standard and expectations of quality
Utilize project management methodologies and tools to guide Regulatory teams in achieving operational excellence, driving teams to achieve clarity on issues, identifying needed decisions, interfacing with regulatory sub-functions while monitoring timelines
Manages the project planning efforts of the Global Regulatory Team in the definition and implementation of the Global Regulatory Strategy planning as well as the operational plan and execution strategies with the team; obtains buy-in of all team members and is responsible for maintaining the Regulatory Plan and communicating changes rapidly
Escalate timeline concerns or obstacles to the Regulatory management, including risks and issues that may impact the project timelines and engages appropriate representatives to manage outcomes. Follows issues through to resolution, ensuring that all regulatory functions are aligned and keeps leadership informed of critical considerations (e.g. resources, team health etc.)
Consider opportunities for continuous Regulatory process improvement
Support development and implementation of novel analytics and metric models which provide flexible functional support for individual projects and our portfolio. This includes supporting the development and maintenance of models, simulations, and frameworks that drive the capacity and resource planning process for the department long range planning. Additionally, assist in development of automated tools and templates to help manage workload

QUALIFICATIONS:

Bachelor’s Degree is required. Science, Engineering, Computer Science, or business-related field preferred
5+ years pharmaceutical industry experience, with 3+ in Regulatory. Previous drug development experience is preferred (e.g. Regulatory, Clinical, CMC, or other development related function)
Substantial experience working within Regulatory Affairs with a fluent understanding of drug development
Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a matrix environment
Ability to mentor and develop skills of team members; ability to articulate and establish business processes
Qualified project management experience; advanced expertise with project management related software and tools (i.e. MS Project, SharePoint, Veeva, etc. or comparable technology)
Proven ability to communicate clearly and present key information objectively; demonstrated ability to clearly communicate/ prepare presentations for management
Analytical and Problem-Solving Skills – ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem. Excellent ability to understand complex issues and propose creative and achievable solutions
Leadership Skills – ability to lead and motivate team members, without direct line management responsibility. Develops, uses, and shares knowledge and uses strong interpersonal skills to influence and guide others (both inside and outside the department)
Strategic Approach – identifies, create, and implement processes for Regulatory Project Management
Presentation skills – create and deliver presentations with appropriate messaging and focused recommendations
Willingness to travel to various meetings, including overnight trips
Recent hands-on experience with the planning and submission of NDAs and MAAs in electronic format preferred
Must have solid foundation in science obtained through academics and business experience
Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication

Qualifications
Education
Required

Bachelors or better in Science or related field.

Experience
Required

5 years: 5+ years pharmaceutical industry experience, with 3+ in Regulatory. Previous drug development experience is preferred (e.g. Regulatory, Clinical, CMC, or other development related function)

Learn more here

Job posted: 2020-11-12