LifeScan was founded in 1981 to provide solutions for people with Diabetes, focusing on the design and manufacture of test strips and electronic meters for blood glucose testing.
Following the launch of the Onetouch brand in 1987, LifeScan has expanded to over 90 countries, serving over 20 Million patients worldwide and is the market leader.
The business employs around 2,400 people worldwide with hubs in Chesterbrook USA, Inverness UK and Zug Switzerland.
This role is for an experienced Senior Regulatory Affairs Program Lead, Policy & Intelligence working within the Global Regulatory Affairs team at Lifescan.
The Sr. Regulatory Affairs Program Lead is responsible for the surveillance of Regulatory Intelligence sources of potential impact to LifeScan with a US geographic focus.
He/she will provide analysis of new regulatory guidance, laws and competitive dynamics and in the context of its potential impact on regulatory strategy and product development relevant to LifeScan for the US and Globally.
In conjunction with the Manager of Regulatory Policy & Intelligence the Sr. Regulatory Affairs Program Lead will also be responsible for establishing and maintaining a Regulatory Affairs Policy process for the Lifescan Business.
The position reports into the Manager of Regulatory Policy & Intelligence and will be based in Wayne, Pennsylvania.
Job Focus: Monitor and assess the US and global regulatory environment to anticipate and communicate regulatory trends through an understanding of regulatory guidelines, regulations and laws that may have an impact on LifeScan's products and regulatory business processes
Communicate Regulatory Intelligence including impact analyses
Input into the process for assessing draft legislation, regulations, and regulatory guidelines to recommend development of LifeScan-specific positions and technical comments
Collaborate with regulatory affairs leadership and cross functional business partners to translate regulatory objectives into an information management and regulatory intelligence strategy
Effectively communicate (verbally, written, published, unpublished, etc.)
regulatory intelligence to a broad, diverse, and global audience using traditional, and non-traditional communication tools.
Engage with internal and external Key Opinion Leaders to help formulate and shape policies and positions on regulatory topics internally and externally
Interact with the FDA on general and non-product related topics.
This activity is conducted in partnership with the regulatory regional Heads and Regulatory Affairs Director for Strategy
Provide Regulatory Affairs support during internal and external audits
Assists in the development of best practices for Regulatory Affairs processes
Represents Regulatory Affairs on cross-functional business teams as required
Partners with other functions to define and obtain data to assist with regulatory strategy development