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Manager, Regulatory AffairsJoin Parachute • Austin, Texas, United States
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Manager, Regulatory Affairs

Join Parachute
  • US
    Austin, Texas, United States
  • US
    Austin, Texas, United States
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À propos

Manager, Regulatory Affairs

Powered by technology and compassionate design, Parachute has reimagined the plasma donation experience into one that is easier and friendlier. Using a simple app, our members can book donations and track earnings from the palm of their hand. In using a tech-forward approach, we're able to offer each member a highly personable and best-in-class experience that's consistent at each and every visit. Our vision is to introduce an elevated plasma donation experience to markets with smaller populations that's grounded in convenience. This model allows us to positively impact the industry supply chain and help patients gain access to the life-changing medication they need. We have grown from 2 to 50+ operations in ~3 years and are looking for new team members to help us scale to 60+ centers this year alone. We are searching for individuals who share our passion for helping others and are invigorated by the speed at which our start-up moves. Come join us as we help the world gain access to more plasma - one donation at a time.

Key Responsibilities
  • Lead the day-to-day operations of the Regulatory Affairs function, coordinating regulatory strategy, submissions, and compliance activities across Join Parachute's plasma collection network.
  • Manage and prioritize the Regulatory Affairs team's daily workload, ensuring timely completion of FDA submissions, responses to information requests, center licensure activities, and regulatory reporting.
  • Author, review, and submit regulatory filings to FDA/CBER and other regulatory bodies, including BLA supplements, amendments, annual reports, and state licensing applications.
  • Partner cross-functionally with Medical Affairs, Quality, Operations, and Legal to evaluate regulatory impact of operational changes, new programs, and center expansions.
  • Monitor the evolving regulatory landscape for plasma collection and biologics, translating regulatory requirements into practical internal guidance and compliance actions.
  • Support major regulatory initiatives such as new center openings, acquisitions and integrations, and implementation of new technologies or specialty plasma programs.
Skills, Knowledge and Expertise
  • Ability to lead and mentor regulatory staff while maintaining strong individual technical contribution.
  • Strong judgment and problem-solving skills when navigating complex regulatory questions.
  • Clear and confident communicator capable of translating regulatory requirements into practical operational guidance.
  • 5+ years of experience in Regulatory Affairs within a regulated life sciences environment (plasma collection, blood banking, biologics, medical devices, or pharmaceuticals preferred).
  • Demonstrated experience preparing and managing regulatory submissions (e.g., FDA supplements, amendments, registrations, or equivalent regulatory filings).
  • Strong working knowledge of FDA regulatory frameworks applicable to biologics or plasma collection (e.g., 21 CFR 600/606/630/640 or similar regulated environments).
  • Experience coordinating regulatory projects across multiple stakeholders and managing competing submission timelines.
  • Bachelor's degree in life sciences, regulatory affairs, public health, or a related field (advanced degree preferred).
Benefits
  • Career growth opportunities
  • Competitive compensation
  • Medical, Dental, and Vision insurance
  • Paid time off
  • Company paid holidays
About Join Parachute

Parachute is a new kind of plasma donation company that allows individuals to earn money while creating life-saving medicine. Plasma is used to create medicine that treats chronic illnesses, including immune disorders, liver disease, bleeding disorders, and cancer. Right now, there's a severe plasma shortage, which is impacting patients' access to these life-saving treatments. Apply Now

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  • Austin, Texas, United States

Compétences linguistiques

  • English
Avis aux utilisateurs

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