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Alcon · 1 month ago

Director, Global Regulatory Affairs Strategy (NPD/OH)

Fort Worth, Texas

Full-time

Onsite

Director/Executive

10+ years exp

Alcon is a company dedicated to enhancing sight and improving lives through innovative solutions. The Director of Global Regulatory Affairs Strategy will lead a team to ensure compliance with regulations, direct product registration, and negotiate with regulatory agencies for timely approvals.

Health CareManufacturingMedical Device

No H1B

Responsibilities

Lead a team within the Regulatory Affairs developing and implementing strategies for success and alignment with company goals

Lead preparation of global regulatory plans and product strategies for assigned products

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

Guide teams on product development, safety, efficacy, and compliance while interacting with health authorities

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

Provide regulatory strategies and risk assessments/mitigation plans for new product introductions and product changes, maintaining regulatory compliance

Support products in the medical device and/or pharmaceutical family, ensuring adherence to relevant regulations

Ensure compliance with Good Practice (GxP) regulations, Standard Operating Procedures (SOPs), and quality control, maintaining accurate documentation and completing required training

Lead globally aligned regulatory strategies across development portfolios, marketed products, and line extensions

Focus on talent development to enhance capabilities

Manage post-approval commitments and lifecycle management

Lead and supervise regulatory associates, ensuring synergy across projects and driving competitive advantage through strategic decision-making

Qualification

Regulatory AffairsProduct RegistrationStrategic GuidanceLeadershipRisk AssessmentGxP ComplianceProduct DevelopmentCommunication SkillsTeam Collaboration