Regulatory Affairs Specialist V

Job Title:  Regulatory Affairs Specialist V
Job Location - Lake Forest, CA
Duration - 09 months

Job Overview

The role involves setting or executing regulatory strategy, leading and managing as a strategist, ensuring local product registration, facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. The candidate 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 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 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.

Additional Information

Location: Onsite, Lake Forest, CA