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Alcon · 1 day ago

Senior Director, Regulatory Affairs Strategy & BD&L

Fort Worth, TX

Full-time

Onsite

Director/Executive

12+ years exp

Alcon is a company dedicated to enhancing sight and improving global eye health. The Senior Director, Regulatory Affairs Strategy & BD&L is responsible for developing strategies for Quality and Regulatory oversight, leading product registration, and providing strategic guidance to ensure compliance with regulations while supporting business development activities.

Health CareManufacturingMedical Device

No H1B

Responsibilities

Lead multiple departments or a large division within the Regulatory Affairs team, providing strategic leadership and ensuring compliance with regulatory requirements

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

Manage and provide regulatory support on business development and licensing activities that aligns with corporate strategy

Manage and participate in conducting regulatory due diligence activities

Direct the development and submission of product/process registrations, progress reports, supplements, amendments, and periodic experience reports

Provide strategic product direction to teams, interact and negotiate evidence requirements with regulatory agencies, and ensure rapid and timely approval of products and their continued approval

Advise development and commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and appropriate regulations and interpretations

Oversee the execution and coordination of various regulatory affairs activities, including product submissions, renewals, and updates by coordinating between plants, agents, and continuously communicating with all parties involved to ensure timely submission and approvals

Provide regulatory strategies and risk assessments/mitigation for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage

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

Lead strategic planning, cross-functional collaboration, advanced problem-solving, and strong communication skills to impact multiple departments to ensure synergy across projects, driving competitive advantage through strategic decision-making, and the overall business outcomes

Focus on talent development to enhance capabilities

Ensure all associates adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training

Contribute to the overall compliance of the organization and commit to continuous improvement in operations

All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations

Qualification

Regulatory AffairsStrategic PlanningProduct RegistrationLeadershipGxP ComplianceBusiness DevelopmentRisk AssessmentCommunication SkillsProblem SolvingTeam Collaboration