About Relay Therapeutics
Backed by GV and SoftBank VF.
About the role
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. 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.
What they're looking for
- Bachelor or advanced degree in Pharmaceutical Sciences, Chemistry or related fields
- Experience with authoring/review/providing CMC content for CMC/quality submissions including IND and IMPD development/maintenance
- Knowledge of eCTD Modules 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
More about this role
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.
- With minimal supervision, accountable for developing and leading the execution of regulatory CMC investigational, registration and/or post-approval strategies for Relay's development programs/products.
- Develop and execute CMC global submission plans and timelines in accordance with project goals
- Strong and deep foundational understanding of global RA CMC regulations and guidelines.
- Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance.
- Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions.
- Apply global regulatory CMC knowledge to address and overcome challenges that arise during development and commercialization.
- Responsible for leading and coordination of responses to CMC questions/RFIs from regulatory authorities in conjunction with CMC and regulatory...
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