Regulatory Affairs Project Leader - Positive Work Culture

For further inquiries regarding the following opportunity, please contact one of our Talent Specialists

Divya | 224 369-2969

Rashi | 630-847-1027

Title: Regulatory Affairs Project Leader
Location:Santa Clara, CA
Duration: 1 Year

• Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.
• Communicates issues to management through project management tracking and issue briefings.
• Position is highly visible to internal and external stakeholders.
• High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict.
• Prior regulatory experience in the medical device, food, dietary supplement or pharmaceutical industry is strongly preferred, but not required.
• Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.
• Ability to manage and track broad and strategic projects.
• Ability to communicate effectively in writing crisp briefings and issue analysis.
• Demonstrated ability to work effectively in a team environment.
• Responsible for tracking and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities.
• Responsible for effective communication of regulatory requirements to project teams and internal customers.

• RA submission experience and EU & MU submissions experience
• Good writing and communication skills - Word, Excel
• Day to day registrations - will train to do this
• Up to 200 pages of documentation formatting
• Complete technical documents for different Countries and submit to government agencies as well as the US.