Simplify Logo

Full-Time

Director – Regulatory Affairs

Confirmed live in the last 24 hours

Relay Therapeutics

Relay Therapeutics

201-500 employees

Biotech company focused on drug discovery

Healthcare
Biotechnology

Senior, Expert

Cambridge, MA, USA

Category
Risk & Compliance
Legal & Compliance
Required Skills
Communications
Requirements
  • 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.
  • Comprehensive knowledge of the drug development process and 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.
  • Experience in interpretation of regulations, guidelines, and policy statements.
  • Strong verbal and written communication skills, including the ability to present strategic topics/issues to project teams, management and regulatory agencies.
Responsibilities
  • Define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline.
  • Serve as the global regulatory lead on relevant project teams to formulate and execute development strategies for developmental programs.
  • Lead the preparation and submission of high quality domestic and global regulatory submission documents (i.e. IND, CTA, NDA/MAA).
  • Lead the development of response strategies to regulators.
  • Communicate with the global regulatory authorities and lead the preparation and conduct of meetings with health authorities.
  • Develop robust briefing packages and comprehensive meeting preparation to maximize outcomes of meetings.
  • Integrate knowledge of current legislation, guidelines and other regulatory intelligence into the development strategies and ensure compliance with regulatory filing and reporting requirements.
  • Proactively identify regulatory opportunities and risks and propose alternative approaches and mitigations to resolve development program challenges.
  • Lead the efforts to plan and obtain regulatory designations including but not limited to breakthrough therapy designations, fast-track designations, and orphan drug designations.
  • Provide oversight to the global regulatory activities that are performed by our Clinical Research Organization (CROs) and regulatory vendors.
  • 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 traditional approaches. 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 impactful medicines for patients, and it is actively conducting clinical trials to ensure the safety and effectiveness of its drug candidates.

Company Stage

IPO

Total Funding

$1.2B

Headquarters

Cambridge, Massachusetts

Founded

2016

Growth & Insights
Headcount

6 month growth

-2%

1 year growth

-10%

2 year growth

-2%
Simplify Jobs

Simplify's Take

What believers are saying

  • Relay's focus on precision oncology and genetic diseases positions it at the forefront of personalized medicine, offering significant growth potential.
  • Recent investments and financing, including a $30 million private placement and $400 million Series C financing, indicate strong financial backing and investor confidence.
  • Initial clinical data for RLY-2608 and other promising drug candidates highlight the company's potential for successful therapeutic developments.

What critics are saying

  • The highly competitive biotech sector requires continuous innovation to maintain a leading position.
  • Dependence on strategic partnerships and licensing agreements could pose risks if collaborations do not yield expected results.

What makes Relay Therapeutics unique

  • Relay Therapeutics places protein motion at the core of its drug discovery process, a unique approach that sets it apart from traditional methods.
  • The Dynamo™ platform combines experimental and computational techniques to target previously undruggable proteins, expanding treatment possibilities.
  • Strategic collaborations, such as the one with Genentech, validate the potential of Relay's innovative technology and approach.

Benefits

Medical, dental, vision

Life, disability, & FSA

401k

Commuter benefits

Parental leave

Home office stipend

Tuition reimbursement

PTO