Johnson & Johnson Careers
Senior Regulatory Affairs Program Lead
Requisition ID: 5179181022
Johnson & Johnson Vision, a member of the Johnson & Johnson Family of Companies, is currently seeking a Senior Regulatory Affairs Program Lead to be based in either Jacksonville, FL, Santa Ana, CA or Milpitas CA. 25-35% travel is required.
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 Sr. Regulatory Affairs Program Lead, under limited supervision, will be responsible for managing and providing supervision to the registration project leads related to meeting regulatory requirements in terms of registration activities related to new product development, new product introduction, renewals and post approval changes for Asia Pacific, Japan, Latin America and Europe, Middle East and Africa. The individual will help identify the least burdensome approach to promote speed to market and compliance with applicable regulations. This individual will work closely with the regional leads and the RegOps lead to ensure a clear understanding of the health authority (HA) requirements for each request/submission. This individual will be responsible for ensuring the required high-quality documentation is dispatched to the local teams for on-time HA submission per the agreed upon schedule. This individual will be responsible for ensuring on-going and frequent communication with the regional leads and key stakeholders. This individual may also be responsible for ensuring that any new external requirements (e.g. regulations, standards, etc.) are identified and assessed in a timely manner as well as any other sub-functional areas within the department as needed.
The Sr. Regulatory Affairs Program Lead, Regulatory Affairs organizes cross-functional teams as needed and provides project leadership on a worldwide basis in order to achieve desired outcomes within defined timeframes. The Lead facilitates mentoring for the Regulatory Affairs associates. This individual will provide Regulatory Affairs support during internal and external audits. You will assist in the development of best practices for RA processes, partners with other functions to define and obtain data to assist with regulatory submission.
- A minimum of a Bachelor’s degree is required. A concentration in science, biomedical engineering, medical/scientific writing, public health administration is preferred. An Advanced Degree (e.g. M.S., PhD, etc.) is preferred.
- A minimum of 6 years of business experience and 4 years working in Regulatory Affairs is required.
- Experience in any one of the following industries: medical device, pharmaceutical or OTC regulatory affairs is required.
- A successful track record of supporting project teams and preparing submissions for international product registrations is preferred.
- Previous people management experience is strongly preferred.
- Solid Knowledge of health authority (HA) regulatory processes for Class II and Class III devices is preferred.
- Experience collaborating with globally dispersed teams is preferred
- Previous experience working with cross functional teams within a matrix environment is required.
- Demonstrable track record of successfully managing/leading multiple projects simultaneously is preferred.
- The position will be based in one of the following locations (Jacksonville, FL, Santa Ana, CA or Milpitas CA) and may require 25-35% domestic and/or international travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Florida-Jacksonville-7500 Centurion Parkway
North America-United States-California-Milpitas, United States-California-Milpitas, United States-California-Santa Ana
Johnson & Johnson Vision Care, Inc. (6094)