J&J Family of Companies Manager Regulatory Affairs in Helena, Montana
Johnson & Johnson Vision, a member of the Johnson & Johnson Family of Companies, is currently seeking a Manager, Regulatory Affairs to be preferable based in Jacksonville, FL but will consider a remote based employee in the United States or United Kingdom.
Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio.
The Manager Regulatory Affairs Business Excellence leads the implementation of a continuous improvement culture within the JJV Regulatory Affairs (RA) department. Combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation and drives measurable process improvements for the organization. Responsible for providing direction regarding the development, design and utilization of regulatory information, through the use of appropriate analytical tools to establish metrics, capacity planning and communication of trends and other insights that enable Regulatory Affairs to accelerate and maximize the success of obtaining product registrations and supporting lifecycle management of JJV products globally.
POSITION DUTIES & RESPONSIBILITES:
Manages a portfolio of process improvement projects across Regulatory Affairs (RA). Drives the process of identifying, defining, and prioritizing functional and cross-functional initiatives. Effectively manages across projects in the portfolio to ensure alignment and consistency with business strategy and to drive measurable process improvements for the organization.
Identifies opportunities to improve quality, reduce cycle time, and increase operational efficiency. Leads the planning and execution of high-impact process improvement projects.
Drives a culture of Business Process Excellence to identify mechanisms to improve overall operational efficiency by influencing continual improvement of IT systems, tools and platforms used by the RA organization.
Identifies, prepares, and facilitates workshops to drive the identification and execution of process improvement initiatives.
Develops compelling value propositions and business cases for proposed initiatives. Collaborates effectively with management, Subject Matter Experts (SMEs), Quality Systems, and peers to design cross-functional solutions.
Enables global regulatory compliance by defining and executing metrics and reporting protocols to monitor RA process effectiveness and compliance across the globe; directs the collection and reporting of process performance metrics for new and ongoing initiatives.
Functional and Technical Competencies:
Works independently in a role that demonstrates organizational influence within or across RA sub-functions and related functions. Transforms concepts into executable initiatives, and drives definition of project scope, timelines and deliverables. Seeks input from and forges agreements among sponsors regarding initiative goals and objectives.
Ability to assess the effectiveness of regulatory systems and to lead improvement initiatives as required.
Leads project teams effectively. Escalates and drives resolution of project issues. Demonstrates effective group facilitation skills and ability to drive consensus among team members regarding process changes.
May manage and/or mentor more junior team members/project managers.
Strong verbal and written communication skills
Experience in management of talent both direct &/or through an outsourced model is preferred
Ability to work effectively with diverse and global audiences and personnel
Ability to interact with senior management executives
Ability to work collaboratively in a matrix environment, building local and global partnerships is required
Strong attention to detail and problem solving skills
Must be fluent in English both written and verbal
Connect: Cultivate strong internal partnerships and collaborations both within RA and across business functions
Shape: Drive innovative approaches and challenge the status quo to drive a culture of continuous improvement.
Lead: Develop self and any directly responsible talent; provide constructive conversations with vendors to ensure outsourced resources are conducting themselves in accordance with our Credo and delivering on agreed expectations.
Deliver: Demonstrate a global and enterprise wide mind set.
Bachelors degree in engineering, life sciences (e.g., biology, chemistry), information systems, or related field
Advanced degree preferred
A minimum of 6 years of relevant professional experience is required, which includes experience in a regulated industry
3+ years experience in process improvement and demonstrated experience with use of Lean tools required.
Six Sigma Certification preferred.
Strong project management skills required
Medical device experience preferred.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Florida-Jacksonville-7500 Centurion Parkway
North America-United States, Europe/Middle East/Africa-United Kingdom
Johnson & Johnson Vision Care, Inc. (6094)