Let’s get started
By clicking ‘Next’, I agree to the Terms of Service
and Privacy Policy, and consent to receive emails from Rise
Jobs / Job page
Associate Director, Regulatory Affairs image - Rise Careers
Job details

Associate Director, Regulatory Affairs

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. 


$152,000 - $210,000 a year
Cogent Biosciences Glassdoor Company Review
No rating Glassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star icon
Cogent Biosciences DE&I Review
No rating Glassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star icon
CEO of Cogent Biosciences
Cogent Biosciences CEO photo
Unknown name
Approve of CEO

Average salary estimate

$181000 / YEARLY (est.)
min
max
$152000K
$210000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

Similar Jobs
Photo of the Rise User

Join Cogent Biosciences as an Associate/Senior Associate Scientist focused on innovative cell biology within a collaborative research environment.

Photo of the Rise User

As a Regulatory Affairs Manager at Roche, you'll lead efforts in ensuring compliant diagnostics while driving patient access across the globe.

Photo of the Rise User
M&T Bank Hybrid Buffalo, New York, United States
Posted 4 days ago

Join M&T Bank as a Regulatory Affairs Analyst to help manage regulatory interactions and support compliance efforts.

BD is looking for a strategic and experienced Senior Director of Regulatory Affairs to lead their innovation in Dispensing and Pharmacy Automation Platforms.

Photo of the Rise User
Posted 3 days ago

Join AstraZeneca as an Associate Regulatory Affairs Director, where you'll manage regulatory submissions and ensure compliance within a dynamic team.

Photo of the Rise User
Posted 12 days ago

Seeking a skilled Senior Specialist in Regulatory Affairs to join our dynamic team at a leading global health care innovator in De Soto, KS.

Photo of the Rise User
Posted 8 days ago

Seeking an experienced Associate Regulatory Affairs Director to drive regulatory strategies and lead multidisciplinary teams at AstraZeneca.

Photo of the Rise User
MSD Remote USA - Pennsylvania - North Wales (Upper Gwynedd)
Posted 4 days ago

Join Merck & Co. as a Senior Director where you'll shape regulatory strategy and foster compliance in critical data management operations.

Photo of the Rise User

Join Sanofi as a Global Regulatory Affairs, CMC Lead and help shape the future of medicine in a full-time position based in Morristown, NJ.

Photo of the Rise User
Inclusive & Diverse
Rise from Within
Mission Driven
Diversity of Opinions
Work/Life Harmony
Customer-Centric
Fast-Paced
Growth & Learning
Medical Insurance
Dental Insurance
401K Matching
Paid Time-Off
Maternity Leave
Paternity Leave
Mental Health Resources
Flex-Friendly
Photo of the Rise User
Inclusive & Diverse
Rise from Within
Mission Driven
Diversity of Opinions
Work/Life Harmony
Transparent & Candid
Growth & Learning
Fast-Paced
Collaboration over Competition
Take Risks
Friends Outside of Work
Passion for Exploration
Customer-Centric
Reward & Recognition
Feedback Forward
Rapid Growth
Medical Insurance
Paid Time-Off
Maternity Leave
Mental Health Resources
Equity
Paternity Leave
Fully Distributed
Flex-Friendly
Some Meals Provided
Snacks
Social Gatherings
Pet Friendly
Company Retreats
Dental Insurance
Life insurance
Health Savings Account (HSA)
Photo of the Rise User
Inclusive & Diverse
Rise from Within
Mission Driven
Diversity of Opinions
Work/Life Harmony
Transparent & Candid
Growth & Learning
Fast-Paced
Collaboration over Competition
Take Risks
Friends Outside of Work
Passion for Exploration
Customer-Centric
Reward & Recognition
Feedback Forward
Rapid Growth
Medical Insurance
Paid Time-Off
Maternity Leave
Mental Health Resources
Equity
Paternity Leave
Fully Distributed
Flex-Friendly
Some Meals Provided
Snacks
Social Gatherings
Pet Friendly
Company Retreats
Dental Insurance
Life insurance
Health Savings Account (HSA)

Cogent Biosciences is a 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 a...

15 jobs
MATCH
Calculating your matching score...
FUNDING
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
EMPLOYMENT TYPE
Full-time, remote
DATE POSTED
February 19, 2025

Subscribe to Rise newsletter

Risa star 🔮 Hi, I'm Risa! Your AI
Career Copilot
Want to see a list of jobs tailored to
you, just ask me below!
LATEST ACTIVITY
V
Someone from OH, Perrysburg just viewed Junior Project Manager * at Virtual Service Operations
S
Someone from OH, Cincinnati just viewed STNA 7AM-7PM (Assisted Living) at Senior Lifestyle
Photo of the Rise User
Someone from OH, Cincinnati just viewed Mail Sorter at Staffmark
Photo of the Rise User
Someone from OH, Toledo just viewed Event Assistant at Datadog
Photo of the Rise User
Someone from OH, Cincinnati just viewed Senior Analyst, Corporate FP&A at Spotify
Photo of the Rise User
Someone from OH, Cincinnati just viewed Manager, Public Cloud FP&A at Zscaler
Photo of the Rise User
Someone from OH, Cincinnati just viewed Senior Financial Analyst at American Express
Photo of the Rise User
Someone from OH, Cincinnati just viewed Senior Financial Analyst, FP&A at StackAdapt
Photo of the Rise User
Someone from OH, Cincinnati just viewed Senior Financial Analyst (Remote - United States) at Protective
Photo of the Rise User
Someone from OH, Cincinnati just viewed Senior Financial Analyst, Acceptance FP&A at Visa
Photo of the Rise User
Someone from OH, Cincinnati just viewed Remote Inventory Clerk at Datadog
M
Someone from OH, Cincinnati just viewed Virtual File Clerk at MUTW, LLC
Photo of the Rise User
Someone from OH, Cincinnati just viewed Data Processing Clerk at Datadog
Photo of the Rise User
Someone from OH, Solon just viewed Senior Integration Engineer (w/m/d) at Safran
Photo of the Rise User
Someone from OH, North Ridgeville just viewed VP, Product Operations at Centivo
Photo of the Rise User
Someone from OH, North Ridgeville just viewed Associate, Digital Product Operations at American Express
Photo of the Rise User
Someone from OH, North Ridgeville just viewed Project and Operations Manager at Datadog
Photo of the Rise User
Someone from OH, North Ridgeville just viewed Product Operations Manager at LinkedIn
Photo of the Rise User
Someone from OH, North Ridgeville just viewed Senior Operations Manager - Ancillary Products at Cars24