Regulatory Affairs Specialist

7 days ago

Texas, United States Join Parachute Full time
Regulatory Affairs Manager

At Parachute, we're redefining the plasma donation experience with a focus on convenience and compassion. As a Regulatory Affairs Manager, you'll play a critical role in ensuring our operations align with regulatory requirements and industry standards.

Key Responsibilities:
  • Develop and maintain regulatory filings and submissions, ensuring compliance with relevant laws and regulations.
  • Collaborate with the Quality Management System team to implement and maintain our quality management processes.
  • Stay up-to-date with regulatory changes and updates, identifying areas for improvement and implementing necessary adjustments.
  • Author and maintain Donor Center Registrations, BLA applications, and licensure documentation, as well as ongoing regulatory submissions.
  • Lead the creation of reports and documentation needed for regulators, ensuring accuracy and completeness.
Requirements:
  • Bachelor's degree in a relevant field, or equivalent work experience.
  • At least 5 years of industry-related experience, with a strong understanding of source plasma regulations and industry best practices.
  • Excellent organizational skills, attention to detail, and analytical abilities.
  • Strong communication and leadership skills, with the ability to provide clear guidance and direction to the team.

We're looking for a highly motivated and detail-oriented individual to join our team. If you're passionate about regulatory affairs and have a strong background in the source plasma industry, we encourage you to apply.

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