Regulatory Affairs Project Leader

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

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.