Full-Time

Senior Manager

Regulatory Affairs

Posted on 4/30/2024

Relay Therapeutics

Relay Therapeutics

201-500 employees

Precision medicine with protein motion visualization

Data & Analytics
AI & Machine Learning

Senior

Cambridge, MA, USA

Required Skills
Communications
Requirements
  • B.S. and/or M.S. degree
  • 3-4 years of increasing responsibility in regulatory affairs
  • Experience in managing the preparation and submission of regulatory submissions (IND, CTA, NDA/MAA, etc.)
  • Experience in precision oncology, rare disease, and/or companion diagnostic (CDx)
  • Strong verbal and written communication skills
  • Self-motivated and driven with a proactive and flexible working style
Responsibilities
  • Develop and execute innovative regulatory strategies for development programs
  • Manage the preparation and submission of domestic and global regulatory submission documents
  • Communicate with global regulatory authorities and support the preparation of meetings with health authorities
  • Interpret and communicate regulatory guidance to internal stakeholders
  • Support efforts to plan and obtain regulatory designations
  • Provide oversight to global regulatory activities performed by Clinical Research Organization (CROs) and regulatory vendors
  • Assist in the management and maintenance of the regulatory information management system (RIMS)

Relay Therapeutics is a precision medicines company utilizing the Dynamo TM Platform to visualize protein motion in HD movies and employing leading-edge experimental and computational approaches in structural biology, biophysics, chemistry, and biology to more effectively drug targets, with a focus on precision oncology and genetic disease.

Company Stage

IPO

Total Funding

$1.2B

Headquarters

Cambridge, Massachusetts

Founded

2016

Growth & Insights
Headcount

6 month growth

-6%

1 year growth

-5%

2 year growth

11%

Benefits

Medical, dental, vision

Life, disability, & FSA

401k

Commuter benefits

Parental leave

Home office stipend

Tuition reimbursement

PTO