The Opportunity:

As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.

Your Role: 

• You will serve as CMC-regulatory lead for assigned projects.
• Develop and execute CMC global submission plans and timelines in accordance with project goals
• You will lead the preparation/plans, review, and on-time submission of CMC sections for IND/IMPD/CTA, NDA/MAA and other global regulatory filings including IB, DSUR, annual updates, briefing books etc. in conjunction with regulatory affairs and CMC/Pharmaceutical Development leads/SMEs.
• You will be responsible for coordination of responses to CMC questions/RFIs from regulatory authorities in conjunction with CMC and regulatory affairs leads/SMEs.
• You will lead CMC-regulatory activities listed above with cross-functional teams and act as the regulatory CMC liaison between CMC/PD, regulatory affairs and/or program management, as applicable.
• You will lead and manage CMC-regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations, in conjunction and consultation with CMC leadership.
• You will keep abreast of regulatory guidance and technical/scientific developments relevant to projects.

Competencies:

• Strong background in Regulatory Affairs-CMC with a focus on small molecule clinical (IND/IMPD) and/or commercial (NDA/MAA) submissions.
• Proven ability to lead and manage regulatory CMC projects with minimal supervision
• In-depth knowledge of global CMC regulatory requirements and guidelines (e.g. FDA, EMA, ICH).
• Positive attitude, energetic and proactive.
• Strong technical writing and document review skills.
• Excellent organizational skills, ability to multi-task and prioritize assignments, operational creativity, strong problem-solving skills, self-motivated and able to work under pressure.
• Strategic thinking capabilities with forward looking perspective and ability to find solutions, in alignment with management and program goals, strong communication, planning, and collaboration skills
• Attention to detail, follow-up/through skills; ability to work individually and within multi-disciplinary internal and external teams at third parties.
• Ability to effectively manage multiple projects with competing priorities.

Your Qualifications:

• Bachelor or advanced degree in Pharmaceutical Sciences, Chemistry or related fields.
• Minimum of 8+ years of relevant experience in regulatory-CMC and/or within CMC function (e.g. analytical, formulation and process development, QA, QC) in the biotech/pharmaceutical industry with a focus preferably on CMC for small molecules and oral solid products.
• Experience with authoring/review/providing CMC content for CMC/quality submissions including IND and IMPD development/maintenance.
• Knowledge of eCTD Module 3 and QOS requirements for INDs/IMPDs and NDAs/MAAs.
• Experience managing submissions in RIM Veeva or equivalent; document formatting/Quality Control compliant with eCTD templates / requirements.
• Authoring experience of CTD Module 2 & Module 3 sections.

Estimated Salary Range: [$145,000 - $207,000].

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.

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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.

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