Principle Regulatory Affairs Strategy Associate

Principle Regulatory Affairs Strategy Associate

The Principle Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product registration and facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. You will plan and recommend regulatory strategies for pipeline products, actively participate in cross-functional teams, and influence business strategies to address regulatory needs.

Expectations / Responsibilities:

• A self-starter, assertive leader who will be accountable for the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.
• Oversee multiple projects within the Regulatory Affairs Strategy team, ensuring goals are met through self-directed work and effective supervision
• Coordinate regulatory activities, including product submissions, renewals, and updates, by liaising with plants, agents, and governmental authorities to ensure timely submissions and approvals
• Oversee promotional material approval for Client ME/KSA portfolio, ensuring ethical conduct and compliance with national and international laws, codes, and regulations
• Provide regulatory strategies for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage
• Support products in the medical device and/or pharmaceutical families, ensuring adherence to all relevant regulations
• Make decisions impacting project performance and success, requiring project management, advanced problem-solving, effective communication, and industry-specific knowledge
• Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training
• Meet individual job requirements and contribute to the overall compliance of the organization

WHAT YOU'LL BRING: Bachelor's Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs) The ability to fluently read, write, understand and communicate in English 7 Years of Relevant Experience 5 Years of Demonstrated Leadership Location : Onsite, Lake Forest, CA Travel Requirements : 0%