Regulatory Affairs Manager
Apply NowCompany: Join Parachute LLC
Location: Austin, TX 78745
Description:
Who Are We?
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 medication they need.
We have grown from 2 to 30 operations in less than three years and plan to continue our rapid expansion. We are looking for people who share in 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.
What You'll Do:
As the Regulatory Affairs Manager at Join Parachute, you will play a key role in executing the day-to-day regulatory processes for our expanding product portfolio. You will manage a team to ensure that our products comply with all regulatory requirements and support the Director of Regulatory Affairs in shaping strategic regulatory initiatives. You'll be responsible for overseeing compliance processes, coordinating regulatory filings, and ensuring effective communication with internal teams and regulatory agencies.
Who You Are:
Benefits
Other details
Apply Now
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 medication they need.
We have grown from 2 to 30 operations in less than three years and plan to continue our rapid expansion. We are looking for people who share in 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.
What You'll Do:
As the Regulatory Affairs Manager at Join Parachute, you will play a key role in executing the day-to-day regulatory processes for our expanding product portfolio. You will manage a team to ensure that our products comply with all regulatory requirements and support the Director of Regulatory Affairs in shaping strategic regulatory initiatives. You'll be responsible for overseeing compliance processes, coordinating regulatory filings, and ensuring effective communication with internal teams and regulatory agencies.
- Oversee the daily operations of the regulatory affairs team, providing guidance, support, and mentorship. Foster a collaborative and efficient environment that promotes high-quality work and continuous learning.
- Lead the implementation of regulatory processes and ensure that our growing portfolio of products meets the required regulatory standards. Manage and track regulatory submissions to ensure timely and accurate filings.
- Ensure that regulatory requirements are met for our products, continuously monitoring changes in regulations and ensuring the team stays compliant.
- Partner with product development, sourcing, and business teams to provide regulatory support and guidance.
- Support the Director of Regulatory Affairs in executing regulatory strategies. Contribute to the development of long-term regulatory plans and assist in mitigating risks without hindering business growth.
- Manage day-to-day communications with regulatory agencies, ensuring clear, consistent, and timely interactions. Support the preparation and submission of regulatory filings.
- Identify regulatory challenges and provide solutions, helping to navigate ambiguity in regulatory frameworks while ensuring compliance. Manage risk while supporting ongoing business initiatives.
Who You Are:
- Experienced Manager: You bring a strong background in regulatory affairs and have a proven ability to manage the day-to-day execution of regulatory processes. You are comfortable overseeing a team and ensuring smooth operations in a dynamic environment.
- Detail-Oriented and Organized: You have a strong attention to detail, ensuring that all regulatory processes are followed meticulously. You excel at managing multiple tasks and deadlines simultaneously in a fast-paced environment.
- Regulatory Expert: You are well-versed in FDA regulations and the regulatory requirements for a range of products. You understand the regulatory landscape and know how to ensure compliance across various product categories.
- Collaborative: You are a team player who enjoys working with cross-functional teams. You can explain complex regulatory requirements in a clear and understandable way, ensuring that all stakeholders are aligned and informed.
- Creative Problem Solver: You are skilled at identifying regulatory challenges and developing practical solutions. You can navigate ambiguous or evolving regulatory guidelines while ensuring business growth and compliance.
- Adaptable and Growth-Focused: You thrive in a fast-paced, startup-like environment. You are comfortable with change and can pivot quickly while maintaining a focus on the company's long-term success.
- Strong Communicator: You excel at communicating with internal teams and external regulators, ensuring that all parties are informed and compliant with regulatory requirements.
Benefits
- Competitive compensation with bonus potential
- Medical, Dental, and Vision insurance
- Paid time off
- Company paid holidays
- Career growth opportunities
Other details
- Pay Type Salary
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