Senior Director, Regulatory Affairs Strategy & BD&L

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Sr. Director, Regulatory Affairs Strategy (Management Path) is primarily responsible for developing and driving strategies for Quality and Regulatory oversight.

You will lead product registration, provide strategic guidance, and negotiate with regulatory agencies to ensure timely product approvals. You will also support business development activities and serve as a regulatory liaison, advising on product development, safety, and compliance, while leading a department to align strategies with company goals.
Specifics Include:
* 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.
** What You'll Bring to Alcon
*** Bachelor’s Degree
* The ability to fluently read, write, understand and communicate in English
* 12 Years of Relevant Experience
* 8 Years of Demonstrated Leadership
* Travel:
Minimal

* Work Location:

Onsite – Fort Worth, TX
* Relocation Assistance/Sponsorship:
None
** How you can thrive at Alcon:
*** Work together with colleagues to share standard methodologies and discoveries as work progresses.
* Discover your career in a fresh way through specific growth and development possibilities.
* Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives,…