Associate Director/Director, Regulatory Affairs
Cogent Biosciences
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Posted on Feb 18, 2025
Who We Are
Cogent Biosciences is a publicly traded biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis (SM), a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Top-line results from registration-directed trials in NonAdvanced SM, Advanced SM and GIST are expected in 2025. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.
Our Team
The Senior Manager/Associate Director of Regulatory Affairs will assist in the development and implementation of regulatory strategies to advance Cogent’s precision kinase inhibitors in oncology and rare diseases. This individual will provide strategic input and regulatory support to cross-functional development teams. Working alongside senior Regulatory staff, this individual will be a key contributor to Cogent’s project and regulatory teams.
What You Will Do
- Support global regulatory nonclinical and clinical strategy development and operational regulatory activities for the development, commercialization, and life cycle management of assigned project(s);
- Attend cross-functional team meetings as a key regulatory voice (e.g., protocol reviews, report reviews, development plans)
- Prepare and coordinate timely submission of global regulatory documents and responses to queries from regulatory authorities (e.g., INDs, CTAs, NDAs, MAAs)
- Develops and contributes to content, format and accountability for regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.;-
- Acting as interface with Health Authorities;
- Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions for assigned programs
- Support and organize preparations for Health Authority meetings;
- Research, analyze, interpret, and disseminate information related to regulatory or scientific topics (i.e., from external meetings, workshops, guidance documents, conferences)
- Contribute to the development of internal regulatory policies, processes, and procedures.
What You Bring
- At least 4 years of experience in Regulatory Affairs
- Regulatory filing experience (e.g, INDs, CTAs, NDAs, MAAs or equivalent);
- Experience in rare disease and oncology;
- Solid working knowledge of drug development processes and US regulatory requirements required; knowledge of EU, UK, Canada, ROW regulatory requirements is preferred.
- Strong project management skills, with a track record of delivering high impact results;
- Outstanding and versatile written and oral communication skills;
- Bachelor’s degree required. Advanced degree in a Life Science or related discipline preferred.
Our Locations
Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building.
Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location and we are proud to call this the home of Cogent’s discovery research organization.
Our Offer To You
To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits.
We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
This job is no longer accepting applications
See open jobs at Cogent Biosciences.See open jobs similar to "Associate Director/Director, Regulatory Affairs" F-Prime Capital Partners.