Senior Director, Regulatory Affairs Strategy & BD&L
Alcon
Summary
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.
Job description
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
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
Requirements
- Bachelor's Degree
- The ability to fluently read, write, understand and communicate in English
- 12 Years of Relevant Experience
- 8 Years of Demonstrated Leadership
Benefits
- Health insurance
- Life insurance
- Retirement planning
- Flexible time off
- Relocation assistance
Company overview
Alcon Inc. is the global leader in eye care, dedicated to helping people see brilliantly. Founded in 1945 as a small pharmacy in Fort Worth, Texas, the company has grown into the world's largest eye care device company with complementary businesses in Surgical and Vision Care. As a Swiss-American multinational corporation headquartered in Geneva, Switzerland with major operations in Fort Worth, Texas, Alcon operates in 60 countries and serves patients in over 140 countries. The company's Surgical segment focuses on ophthalmic products for cataract surgery, vitreoretinal surgery, refractive laser surgery, and glaucoma surgery, including implantables, consumables, and surgical equipment. The Vision Care segment comprises daily disposable, reusable, and color-enhancing contact lenses, along with a comprehensive portfolio of ocular health products for dry eye, contact lens care, and ocular allergies. With over 75 years of heritage, Alcon has a long history of industry firsts and makes substantial annual investments in research and development to meet evolving customer needs and advance patient care. The company became an independent publicly-traded entity in 2019 after spinning off from Novartis.