Full-Time

AD / Director

Regulatory Affairs

Posted on 4/12/2024

Relay Therapeutics

Relay Therapeutics

201-500 employees

Biotech company focused on drug discovery

Biotechnology
Healthcare

Senior

Cambridge, MA, USA

Category
Risk & Compliance
Legal & Compliance
Requirements
  • You have earned your B.S and/or M.S. and bring at least 5 years of increasing responsibility in regulatory affairs. Advanced degree or education in a scientific field is a plus.
  • You are results-oriented and have comprehensive knowledge of the drug development process and have a demonstrated record of successful regulatory submissions (IND, CTA, NDA/MAA, etc.)
  • Experience in precision oncology, rare disease and/or companion diagnostic (CDx) is a plus.
  • You are a regulatory interpreter; you have experience in interpretation of regulations, guidelines, and policy statements and know how best to exercise regulatory flexibility.
  • You are a strategic thinker, capable of proposing innovative solutions to regulatory problems.
  • You have strong verbal and written communication skills, including the ability to present strategic topics/issues to project teams, management and regulatory agencies.
  • Self-motivated and driven with a proactive and flexible working style with a passion for impacting patient's lives through regulatory work.
Responsibilities
  • You will serve as the global regulatory lead on relevant project teams to formulate and execute development strategies for developmental programs.
  • You will be the primary contact to interface with FDA and will lead cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDA and MAA submissions.
  • You will be responsible for leading the preparation and submission of high quality domestic and global regulatory submission documents (i.e. IND, CTA, NDA/MAA), as well as leading the development of response strategies to regulators.
  • You will be responsible for communicating with the global regulatory authorities and leading the preparation and conduct of meetings with health authorities, which includes the development of robust briefing packages and comprehensive meeting preparation to maximize outcomes of meetings.
  • You will be responsible for integrating your knowledge of current legislation, guidelines and other regulatory intelligence into the development strategies and ensuring compliance with regulatory filing and reporting requirements.
  • You will be responsible for proactively identifying regulatory opportunities and risks and proposing alternative approaches and mitigations to resolve development program challenges.
  • You will lead the efforts to plan and obtain regulatory designations including but not limited to breakthrough therapy designations, fast-track designations, and orphan drug designations and contribute to the CDx strategy development and submissions.
  • You will provide oversight to the global regulatory activities that are performed by our Clinical Research Organization (CROs) and regulatory vendors.
  • You will lead and mentor junior staff in the regulatory team to support their development and enable program deliverables.

Relay Therapeutics focuses on drug discovery by emphasizing the movement of proteins in its research. The company uses its Dynamo™ platform, which integrates experimental and computational methods, to identify and develop new drugs, particularly for complex diseases that are hard to treat with current therapies. This platform enables Relay to target proteins that have previously been difficult to address, expanding treatment options, especially in precision oncology and genetic diseases. Unlike its competitors, Relay Therapeutics collaborates with major biotech firms, such as Genentech, to validate its technology and generate revenue through licensing and partnerships. The main goal of Relay Therapeutics is to create effective medicines that can significantly improve patients' lives, and it is actively conducting clinical trials to ensure the safety and efficacy of its drug candidates.

Company Stage

IPO

Total Funding

$535M

Headquarters

Cambridge, Massachusetts

Founded

2016

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

2%
Simplify Jobs

Simplify's Take

What believers are saying

  • AI-driven drug discovery complements Relay's computational techniques, enhancing drug development.
  • Quantum computing integration could boost Dynamo's capabilities in drug discovery.
  • Rising personalized medicine trend aligns with Relay's precision medicine focus.

What critics are saying

  • Increased competition from VantAI threatens Relay's market position.
  • Layoffs may impact Relay's operational efficiency and research progress.
  • Reliance on public offerings suggests potential financial instability for Relay.

What makes Relay Therapeutics unique

  • Relay's Dynamo platform targets previously undruggable proteins, expanding treatment possibilities.
  • Focus on protein motion places Relay at the forefront of innovative drug discovery.
  • Relay's precision oncology approach tailors treatments to individual genetic profiles.

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Benefits

Medical, dental, vision

Life, disability, & FSA

401k

Commuter benefits

Parental leave

Home office stipend

Tuition reimbursement

PTO

INACTIVE