Who We Are
Cogent Biosciences is a publicly traded biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent’s lead therapeutic candidate, bezuclastinib (CGT9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis (SM), which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.
Our Team
https://cogent.culturehq.com
This is a unique opportunity to work with Regulatory Operations team to support Regulatory Affairs. This position will work with Regulatory Affairs submission process for US submissions and will be a vital part of working with vendors. Cogent is a place where your input matters -- you will have a direct impact on our process and will help to build our capability as a team. You will also shape the Cogent culture and be a part of a passionate, transparent, and collaborative work environment.
Responsibilities
- Supports Regulatory Affairs with managing IND lifecycle submissions, including scheduling and tracking
- Assist with developing systems and processes to prepare Cogent for an NDA, label approval and commercialization
- Assist with formatting and publishing eCTD compliant documents
- Processes and publishes safety reports and coordinates with CRO for agency submission
- Works extensively with Veeva software, including RIM data entry
- Assist with Veeva change controls and Veeva maintenance
- Trains new hires and employees on Veeva
- Assist with writing and maintaining SOPs
- Communicates with and advises development teams on publishing requirements, as well as maintaining focus and awareness of potential delays, problems, gaps of information, expectations, project steps, milestones and deliverables
- Has thorough understanding of domestic and international regulations and guidelines and can interpret the intent of the regulations and guidelines
- Proactively and independently researches and communicates potential Regulatory Operations issues that could streamline the development process and projects
Qualifications
- BA/BS or equivalent experience
- 10 years’ experience in Regulatory Operations publishing or equivalent in biotech, pharma, or medical device
- 10 years’ experience with RIMs and electronic submission software
- Must be “hands-on”, willing and expected to take on projects and tasks to support the team
- Solid understanding of the processes and interactions essential to produce regulatory submissions
Target Bonus: 10-15%
Exact compensation may vary based on skills, experience, and location.
