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Regulatory Affairs Project Leader

2 months ago

Santa Clara, United States Planet Pharma Full time

1-Year Contract

$50-$52/hour

Duties:

  • 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.

Education:

  • Bachelor's degree required, Masters degree preferred

Experience:

  • Minimum of 3 years experience in regulatory affairs
  • Must have EU & MU submission experience

Skills:

  • Knowledge of US and/or Canadian regulation relating to product and/or device clearance (FDA)

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