Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Location: Lake Forest, CA - ONSITE

Contract Length: 6-8 months with potential to extend

The Principle Regulatory Affairs Strategy Associate, 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 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 TO CLIENT:

• 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