As an integral part of the Regulatory Affairs (RA) team, the RA Program Director translates regulatory strategies and objectives into executable programs. The role will develop program and/or project structure and governance and will ensure the integration of project management methodology to prioritize and deliver transformational regulatory projects globally.
Job Summary:
The RA Program Director reports to the VP, Global Regulatory Affairs, is part of the Regulatory Affairs Leadership Team, and is a critical enabler for the RA team globally. The role will own and oversee the development and execution of key CooperVision RA and RA-driven cross-functional projects globally.
Essential Functions Accountabilities:
Provide structure, governance and leadership to key RA strategic projects needed to deliver RA objectives, ensuring there is clear prioritization and resource allocation (people and budgets) to deliver the project on-time and on budget
Partner with RALT peers, CooperVision leadership and internal/external stakeholders to ensure alignment between business and regulatory strategies
Drive cross-functional/organizational alignment related to projects and/or programs
Lead strategic and tactical reviews of key RA initiatives, projects and/or programs
Define and manage program resource and budget requirements
Define program/project governance and structure
Advise/guide project leads and teams
Develop and deploy program communications/updates to leadership and project/program stakeholders
Identify, escalate and manage program-related risks
Enable the Global RA function to deliver key global priorities through integration of project management methodology and tools
Oversee all aspects of project initiation, planning and delivery
Qualifications
Knowledge, Skills and Abilities:
Demonstrated leadership skills: a proven leader who can lead others through influence
Strategic mindset with the ability to translate strategies into executable plans
Working knowledge of global medical device regulatory framework
Ability to manage balance multiple priorities
Demonstrated problem-solving skills
Strong learning agility
Excellent knowledge of core commercial processes
Ability to achieve results while managing risks
Comfortable planning under conditions of ambiguity
Culturally astute and able to flex style accordingly
Excellent written and verbal communication skills; must be fluent in written and spoken English
Strong interpersonal skills
Advanced skills in Microsoft PowerPoint, Excel, Word and Project Management tools (e.g., Microsoft Project, Smartsheet, etc.)
Work Environment:
Desk based; flexible location
Travel as required, estimated 25-30%
Sedentary to light physical effort necessary to perform the job
There will be extended periods of sitting and using a computer
Experience:
Has led or has worked in a PMO function or Program/Project Management role
Medical Device Regulatory Affairs experience conveying a working knowledge of global medical device regulations
Has successfully led transformational Regulatory projects
A proven track record of success in coordinating/enabling matrix resources in the delivery of a project
Experience setting and supporting strategy development and execution
Experience leading projects requiring high levels of change management
Education:
Bachelors degree or higher required
RAC and/or PMP certification preferred
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