Regulatory Affairs Director

6 days ago


Reston, Virginia, United States Intellectt Inc Full time

Job Summary:

Intellectt Inc is seeking a highly skilled Regulatory Affairs Leader to join our team. As a key member of our organization, you will be responsible for defining and implementing regulatory strategies and priorities in conjunction with management, peers, commercial, and affiliate personnel.

Key Responsibilities:

  • Regulatory Strategy: Assist in the development and implementation of regulatory strategies and priorities to ensure compliance with relevant laws and regulations.
  • Communication: Communicate issues to management through project management tracking and issue briefings, ensuring effective communication with internal and external stakeholders.
  • Project Management: Manage and track broad and strategic projects, ensuring timely completion of regulatory strategies and issues.
  • Team Collaboration: Collaborate effectively with internal customers, including scientists, marketing, quality assurance, product development, and affiliates, to solve problems and communicate regulatory needs.
  • Regulatory Expertise: Possess prior regulatory experience in the medical device, food, dietary supplement, or pharmaceutical industry, with a strong understanding of US and/or Canadian regulations.
  • Leadership: Demonstrate high-level leadership skills, including the ability to negotiate, influence, and manage conflict, while maintaining a high level of effective verbal and written communication skills.

Requirements:

  • Education: Bachelor's degree required, Master's degree preferred.
  • Experience: Minimum of 3 years of experience in regulatory affairs.
  • Skills: Strong knowledge of US and/or Canadian regulations, excellent communication and project management skills, and ability to work effectively in a team environment.


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