IntePros ยท 1 day ago
Reg Affairs Program Manager
United States
Full-time
Remote
Mid, Senior Level
5+ years exp
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Responsibilities
Accountability, this person should have a high say/do ratio and be able to work with other team members in a matrix to support business needs
Organizational skills, this person should be able to manage multiple interrelated projects simultaneously, identify critical path and propose multiple solutions to opportunities to crash schedules when needed.
Stakeholder management, this person will be the face of the department within the Core Team and manage external stakeholders and support the department s internal team through building a close relationship with a high level of collaboration.
This position will be responsible for coordinating the development of Technical Literature.
They will serve as the Core Team member, working cross-functionally to develop timelines and take content change needs back to the Technical Literature team for execution to meet the needs for human factors testing, regulatory submissions and product launches.
This person will working closely with a matrixed team in the department consisting of graphic designers, project coordinators and technical writers to deliver high-quality technical literature to support the Diabetes Operating Unit.
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Monitors and improves tracking / control systems.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.
Manages one or more small-scale, developed or mature programs with well-defined program plans and delivery methodologies.
Is accountable for overall program process, performance, and customer satisfaction.
Provides input to establishing program objectives, timelines, milestones, and budgets.
Recommends new policies and procedures that affect program management.
May have budget accountability for one or more programs.
Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team.
Solves issues through information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans.
Leads, directs and reviews the work of a team of professionals and/or vendors who exercise latitude and independence in their assignments.
Qualification
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Required
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
Accountability, this person should have a high say/do ratio and be able to work with other team members in a matrix to support business needs.
Organizational skills, this person should be able to manage multiple interrelated projects simultaneously, identify critical path and propose multiple solutions to opportunities to crash schedules when needed.
Stakeholder management, this person will be the face of the department within the Core Team and manage external stakeholders and support the department's internal team through building a close relationship with a high level of collaboration.
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Monitors and improves tracking/control systems.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.
Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.
Company
IntePros
IntePros is a results-oriented recruiting solutions and staffing company that uses our Top Gun Recruiting Engine to attract, recruit, and retain elite IT consultants on behalf of our roster of market-leading clients.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Loren Kovalcik
Chief Executive Officer
Company data provided by crunchbase
