Director, Regulatory Affairs Strategy

About the role

The Director, Regulatory Affairs Strategy (Management Path) leads a department within the Regulatory Affairs Strategy team. They develop and implement strategies for success and alignment with company goals, direct product registrations, and negotiate with regulatory agencies to ensure timely product approvals.

Responsibilities

• Lead a department within the Regulatory Affairs Strategy team, developing and implementing 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
• Focus on talent development to enhance capabilities
• Manage 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
• Coordinate regulatory activities for timely approvals and compliance
• Lead and supervise regulatory liaisons, ensuring synergy across projects and driving competitive advantage through strategic decision-making

Requirements

Minimum Qualifications:

• 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

Additional Qualifications:

• Experience in medical device regulatory affairs
• Strong leadership and negotiation skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Knowledge of regulatory guidelines and standards
• Experience with regulatory submissions and approvals
• Ability to manage multiple projects simultaneously

Skills

Essential Skills:

• Strategic thinking and problem-solving
• Regulatory compliance expertise
• Project management and coordination
• Collaborative teamwork
• Effective communication and presentation skills
• Leadership and mentorship

Benefits

Alcon offers a comprehensive benefits package including health, life, retirement, flexible time off, and much more!