Regulatory Affairs Director at Austin
Position Title: Regulatory Affairs Director
Location: Austin, TX
Full Time – Direct Hire
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 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.
Come join us as we help the world gain access to more plasma—one donation at a time.
The Director, Regulatory Affairs is responsible for overseeing the company’s compliance and regulatory strategy. This role develops and maintains the Company’s regulatory filings and submissions, as well as assisting with the overall implementation of the Company’s Quality Management System.
Principal Duties & Responsibilities:
- Execute and deliver regulatory submissions and filings in advance of requisite deadlines.
- Manage and develop the internal audit program including performing internal audits as required.
- Ensure organizational processes conform to standard operating procedures / regulatory requirements.
- Actively scan the regulatory landscape to ensure alignment and identify laws and regulations that impact the Company's policies.
- Under the supervision of the Chief Medical Officer, author and maintain all Donor Center Registrations, BLA applications, licensure documentation, and ongoing regulatory submissions.
- Lead the creation of reports and documentation needed for regulators.
- Assist with the improvement and implementation of the Company’s Quality Management System.
- Liaise directly with the FDA, notified bodies, and other regulatory agencies.
- Collaborate with other senior management and cross-functional project teams to design and implement high-quality regulatory strategies.
- Incorporate a global regulatory strategy into GXP compliance policies, regulatory filings, supply chain operations, marketing, sales, and external partnerships.
- Ensure adequacy of departmental and company standard operating procedures (SOPs) from a GXP perspective.
- Assess all SOP changes for regulatory impact, ensuring facility compliance.
- Provide strategic and technical leadership of Regulatory Affairs activities and deliverables in support of the Company.
- Help to implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA regulations / directives / requirements.
- Work to develop a strategy in the regulatory function via objectives and plans to ensure quality oversight, timely resolution of issues, and early intervention to assure compliance.
- Identify, resolve, or escalate any and all product, process, or customer Quality-related issues that pose risk with respect to the donor, customers, or compliance.
- Work with and contribute to managing external regulatory- and QA-related vendors to drive excellence and meet phase-appropriate regulations and timelines.
- Manage strategy and approach for all inspections & audits in compliance with local and global regulatory agencies and customers.
- Oversee compliance auditing program to fulfill regulatory requirements.
- Respond to requests from regulatory agencies and customers.
- Serve as the primary Company regulator for equipment and software used to ensure compliance.
- Complete necessary regulatory actions for the Company’s continued expansion through additional Donor Center locations.
Knowledge, Skills, & Abilities:
- Ability to maintain excellent organizational skills and attention to detail.
- Ability to solve complex problems and maintain strong analytical skills.
- Ability to provide excellent verbal and written communication.
- Ability to provide strong supervisory and leadership skills to the organization.
- Extensive knowledge of the principles, procedures, and best practices in the source plasma industry, a plus.
- Knowledge of the legal aspects of a Donor Center a plus.
- Proficient with Microsoft Office Suite and related software.
- Direct management of multiple reports and ability to provide counsel to employees at all levels within the Company.
Education and Experience:
- Bachelor’s degree in an engineering, science, or related discipline preferred; advanced degree is a plus.
- Minimum of five (5) years’ direct regulatory affairs and quality assurance experience in the biotech/pharmaceutical industry.