Director, Regulatory Affairs Strategy

About the role

The Director, Regulatory Affairs Strategy (Management Path) leads product registration activities, provides strategic regulatory guidance, and negotiates with regulatory agencies to ensure timely product approvals. They advise on product development, safety, and compliance, and lead a department to align regulatory strategies with company goals.

Responsibilities

• Develop and implement strategies for success and alignment with company goals
• Direct the development and submission of product/process registrations, progress reports, supplements, amendments, and periodic experience reports
• Provide strategic product direction to teams and negotiate evidence requirements with regulatory agencies
• Ensure rapid and timely approval of products and their continued approval
• Serve as the regulatory representative to marketing, research project teams, and government regulatory agencies
• Advise development and commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and regulations
• Oversee regulatory affairs activities, including product submissions, renewals, and updates, ensuring timely submission and approvals
• Oversee promotional material approval, ensuring ethical conduct and compliance with laws and regulations
• Provide regulatory strategies for new product introductions and product changes, maintaining regulatory compliance
• Support products in the medical device family, ensuring adherence to relevant regulations
• Collect and analyze regulations/standards to ensure product compliance and engage in activities of industry associations like Advanced Medical Technology Association (AdvaMed)
• Support post-market inspection and explain approved information to customers, maintaining approval information in internal systems
• Lead globally aligned regulatory strategies across development portfolios, marketed products, and line extensions
• Manage post-approval commitments and lifecycle management
• Guide teams on product development, safety, efficacy, and compliance while interacting with health authorities
• Cook up and supervise regulatory liaisons, ensuring synergy across projects and driving competitive advantage through strategic decision-making

Requirements

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs.; Assoc.+14 yrs.; M.S.+7 yrs.; PhD+6 yrs.)
• The ability to fluently read, write, understand, and communicate in English
• 10 Years of Relevant Experience
• 6 Years of Demonstrated Leadership

Qualifications

• Fluency in English
• Leadership experience

Skills

• Strategic thinking
• Regulatory compliance expertise
• Product development oversight
• Collaborative leadership

Benefits

Alcon offers a comprehensive benefits package including health, life, retirement, flexible time off, and more. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities.