Regulatory Affairs Associate
Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Company’s progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Company’s lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. FX-322 is being evaluated in multiple ongoing clinical studies in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including multiple sclerosis.
The Regulatory Affairs Associate reports to the Vice President of Regulatory Affairs and is responsible for supporting Regulatory Affairs processes, including coordinating regulatory document generation, reviews, and approvals, while also maintaining documentation logs and providing administrative and technical support to the department.
Key Responsibilities Include:
- Provide support to regulatory operations including regulatory document preparation, review and coordination, maintenance of reports, logs, libraries and documentation. Maintain secure RA documents and records (e.g. scan, print, file)
- Provide exceptional attention to detail and ability to identify processing and documentation errors from all sources
- Demonstrate exceptional work organization, focus and tracking on assigned tasks and timelines, while working independently
- Coordinate regulatory calendar, prepare agendas and minutes as needed to facilitate and coordinate meetings
- Review and coordinate consultant and project timesheets, CDAs, consulting agreements/proposals, invoices, and payments as needed
- Coordinate and track reviews and approvals of regulatory submissions and projects between internal contributors, external reviewers and outsourced publishing. Identify circumstances that may impact timelines
- Compose, edit, compile, and distribute reports and documents. Prioritize and summarize information
- Maintain correspondence logs, submission planners, and regulatory and quality document libraries; Maintain RA libraries including clinical and marketing applications and controlled documents and maintain competitor clinical and regulatory information
- Provide the necessary documentation and support materials for meetings, such as status updates on submissions and projects updates. Format data into presentations for use in meetings and reports
- Provide additional administrative and planning support as needed
- Bachelor’s Degree required, MS degree in life/health/technical sciences preferred
- Experience in regulated industry or IT, biotech or pharmaceutical industry preferred
- Experience in medical device or drug quality systems or regulatory submissions preferred
- Advanced Word, Adobe publishing, Excel and PowerPoint skills
- Ability to work both independently the with minimal direction and within project teams, committees, etc. to attain group goals
- Demonstrate excellent communication skills, strong organizational skills, including the ability to prioritize personal and direct reports workload
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
Working at Frequency
At Frequency Therapeutics, we believe that we have the best chance to achieve our mission by creating an environment where our collective problem-solving and leadership skills are put to work, so collaboratively, we can solve some of the most complex challenges in medicine. We are focused on developing new treatments to potentially help millions of patients with novel therapeutics. This requires both a willingness to be audacious in our pursuits and relentless in our focus and commitment to research and patients. We look for individuals who are both highly skilled and self-aware, who are willing to challenge leadership and their colleagues, are entrepreneurial by nature and who are undeterred by uncertainty.
Please visit www.frequencytx.comfor more information.
We offer a competitive compensation and benefit package. For consideration, please submit CV and cover letter.