Senior Regulatory Affairs Associate

Alcon•Lake Forest, CA

6d•$102,850 - $133,100•Onsite

About The Position

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. Associate, Regulatory Affairs Strategy (Professional Path), reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily responsible for coordinating regulatory compliance for Alcon's product portfolio, managing local initiatives, and supporting business requests for product and regulatory information. You will also participate in cross-functional teams for risk management and produce compliance metrics. Occasionally, you will represent the Regulatory Affairs Manager, when requested.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+16yrs; M.S.+0 yrs)
The ability to fluently read, write, understand and communicate in English
2 Years of Relevant Experience
1 Years of Demonstrated Leadership

Responsibilities

Operational support / execution tasks associated with LCM work
Working with Reg. Ops. to complete user fee requests
Data requests to R&D for tender applications, one-off requests for country-specific technical information, maintenance of project status master slide deck for regional RA calls, drafting (not signing) explanation letters, and other administrative requirements for HA queries
Perform specialized tasks and conduct independent research within the Regulatory Affairs Strategy team to optimize outcomes and contribute to project goals
Coordinate product submissions, renewals, and updates by liaising with plants, agents, and authorities to ensure timely submissions and approvals
Oversee promotional material approval for Alcon ME/KSA portfolio, ensuring ethical conduct and compliance with laws, codes, and regulations
Provide regulatory strategies for new product introductions and changes, maintaining compliance to drive competitive advantage
Support medical device and/or pharmaceutical products, ensuring adherence to relevant regulations
Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining documentation, ensuring quality control, and completing required training
ROW submissions for new projects, with supervision
Assistance with LCM work, with supervision
Change assessments / RIARs
PPRR work, registration renewals, TF maintenance, etc.