Regulatory Affairs Program Director

Job Description

Scope:

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:

• Bachelor’s degree or higher required
• RAC and/or PMP certification preferred
  
  
  

Applicable to the US Only:

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $141,317.00 and $201,882.00 USDs per year and may include cost of living adjustments. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran

About Us

CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.

At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and a diverse, inclusive, employee-centric culture fuel a deeply engaged, high performing organization.

CooperVision employees pride themselves on being proactive, innovative, flexible and friendly. That’s a strong reflection of our corporate culture—and part of the reason CooperVision may be a great workplace for you.