The Opportunity: 

We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to ​define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. 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. 

Your Role:  

• You will work side by side with your regulatory and research and development colleagues to develop​ and execute innovative regulatory strategies for our fast-paced programs, including the implementation of non-clinical and clinical regualtory strategy for relevant products. 

• You will be responsible for leading the preparation and submission of high quality domestic and global regualtory 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 regualtory 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 regualtory intelligence into the development strategies and ensuring compliance with regualtory 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.  

Your Background:  

• 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 regualtory agencies. 

• Self-motivated and driven with a proactive and flexible working style with a passion for impacting patient's lives through regulatory work. 

Estimated Salary Range: [$144,000 - $205,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

#JO1

The Opportunity 

We are seeking a highly motivated and strategic leader to direct analytical development and quality control strategies in support of drug substance and drug product development across all stages of development. In this role, you will establish and lead the analytical strategy for our small molecule programs and serve as a key partner across CMC, Regulatory, and Quality functions. 

You will work closely with internal stakeholders and external partners, including CMOs and CROs, to ensure robust analytical methods and quality systems are implemented to support development, manufacturing, and regulatory submissions. 

This is a highly visible leadership role with responsibility for shaping analytical strategies that enable the successful advancement of our clinical pipeline. 

Your Role 

• You will be responsible for setting and executing the analytical development and quality control strategy across our development programs, ensuring phase-appropriate analytical methods and control strategies are in place to support drug substance (DS) and drug product (DP) development. 

• You will lead analytical method development, validation, and lifecycle management activities required for the full characterization of small molecule NCEs. 

• You will provide scientific and strategic oversight of external laboratories, CMOs, and CROs conducting analytical development, method validation, release testing, and stability testing in support of Relay clinical candidates. 

• You will review and approve analytical development strategies, method transfer and validation protocols, datasets, and final reports. 

• You will oversee QC testing performed at external analytical laboratories and DS/DP manufacturing sites to ensure compliance with cGMP standards. 

• You will provide quality oversight and approval of cGMP QC documentation, including change controls, deviations, CAPAs, analytical procedures, and validation protocols. 

• You will review analytical data packages and raw data from third-party laboratories to support batch disposition and release. 

• You will oversee the Reference Standard program, including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories. 

• You will lead activities related to critical quality attributes (CQAs), specifications, stability strategies, data trending, shelf life determinations, and expiry dating for drug substance and drug product. 

• You will define and implement phase-appropriate analytical and stability strategies across all clinical development programs. 

• You will author and review QC and analytical sections of regulatory filings, including INDs and NDAs, and provide technical leadership for responses to Health Authority questions. 

• You will represent the analytical function in cross-functional program teams and contribute to overall CMC strategy and regulatory planning. 

• You will build strong partnerships across Regulatory Affairs, CMC, Quality Assurance, and external partners to ensure alignment on development and regulatory strategies. 

• As the analytical function grows, you may mentor and lead internal scientists or matrix teams, while establishing scalable processes and best practices. 

Your Background 

• You have earned an MS or PhD in Analytical Chemistry, Biochemistry, Biotechnology, or a related discipline, with 10+ years of industry experience, including significant experience leading analytical development activities in a pharmaceutical or biotechnology environment. 

• You have deep expertise in analytical development, method validation, technology transfer, troubleshooting, and quality control for small molecule drug development. 

• You have experience developing analytical strategies across multiple phases of development, including IND-enabling and late-stage programs. 

• Experience supporting regulatory filings (IND, NDA, or equivalent) and interacting with global regulatory agencies such as the FDA, EMA, or PMDA is strongly preferred. 

• You possess strong technical expertise in analytical methods for small molecule drug substances and oral solid dosage forms. 

• You are an effective communicator who can collaborate successfully with cross-functional internal teams, contract laboratories, and manufacturing partners. 
• You are comfortable managing multiple programs and priorities in a dynamic development environment.

Estimated Salary Range: [$160,000 - $228,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

#BP1

**Please apply via the link below**

Regional Medical Science Liaison - BC/Oncology - South Korea

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