Kardigan
About Kardigan
Kardigan is a heart health company focused on making cardiovascular disease preventable, curable, and no longer the leading cause of death. Our mission is to develop multiple targeted treatments in parallel to bring patients closer to cures. We are guided by values that prioritize patients, authenticity, curiosity, teamwork, and enabling the impossible. Position Title: Senior Director, CMC Regulatory Department: Regulatory Affairs Reports To: Head of CMC Regulatory Location: South San Francisco, CA – On-site 4 days per week (Mon to Thurs) Job Overview
Kardigan is seeking a Senior Director, CMC Regulatory to support our mission by leading CMC Regulatory activities to advance late-stage clinical assets through clinical development toward marketing approval. You will help define CMC Regulatory strategies and execute them in submissions and health authority interactions, in close collaboration with cross-functional partners. This position reports to the Head of CMC Regulatory. Essential Duties and Responsibilities
Lead the development and execution of CMC regulatory strategies in collaboration with cross-functional teams to align with program objectives and timelines. Proactively manage regulatory CMC aspects of programs to ensure on-time delivery of global, high-quality submissions across all development-stage programs. Manage regulatory interactions with global health authorities, including meeting preparation and participation, responses to questions, and negotiations. Provide regulatory expertise on CMC strategies to cross-functional teams, anticipating regulatory concerns and proposing innovative solutions. Ensure compliance with global CMC requirements (FDA, EMA, ICH) and monitor regulatory trends and changes. Evaluate proposed manufacturing and quality changes for impact to submissions and provide strategic guidance for optimal implementation. Help develop and implement department practices, policies, processes, and SOPs. Manage internal or external staff as needed. Qualifications and Preferred Skills
Bachelor’s degree in a scientific discipline required; advanced degree in Chemistry preferred. Minimum of 10 years of industry experience, with the majority in CMC Regulatory Affairs or related roles. Experience with global early and late-phase submissions (IND/IMPD, NDA/MAA, amendments, annual reports) and health authority interactions. Prior small molecule experience preferred. Excellent knowledge of FDA, EMA, and ICH guidelines and regulations. Strong collaboration and communication skills across all levels and functions. Ability to manage multiple assignments in a fast-paced environment. Compensation
Exact compensation may vary based on skills, experience, and location. Pay range: $238,000 - $310,000 USD
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Kardigan is a heart health company focused on making cardiovascular disease preventable, curable, and no longer the leading cause of death. Our mission is to develop multiple targeted treatments in parallel to bring patients closer to cures. We are guided by values that prioritize patients, authenticity, curiosity, teamwork, and enabling the impossible. Position Title: Senior Director, CMC Regulatory Department: Regulatory Affairs Reports To: Head of CMC Regulatory Location: South San Francisco, CA – On-site 4 days per week (Mon to Thurs) Job Overview
Kardigan is seeking a Senior Director, CMC Regulatory to support our mission by leading CMC Regulatory activities to advance late-stage clinical assets through clinical development toward marketing approval. You will help define CMC Regulatory strategies and execute them in submissions and health authority interactions, in close collaboration with cross-functional partners. This position reports to the Head of CMC Regulatory. Essential Duties and Responsibilities
Lead the development and execution of CMC regulatory strategies in collaboration with cross-functional teams to align with program objectives and timelines. Proactively manage regulatory CMC aspects of programs to ensure on-time delivery of global, high-quality submissions across all development-stage programs. Manage regulatory interactions with global health authorities, including meeting preparation and participation, responses to questions, and negotiations. Provide regulatory expertise on CMC strategies to cross-functional teams, anticipating regulatory concerns and proposing innovative solutions. Ensure compliance with global CMC requirements (FDA, EMA, ICH) and monitor regulatory trends and changes. Evaluate proposed manufacturing and quality changes for impact to submissions and provide strategic guidance for optimal implementation. Help develop and implement department practices, policies, processes, and SOPs. Manage internal or external staff as needed. Qualifications and Preferred Skills
Bachelor’s degree in a scientific discipline required; advanced degree in Chemistry preferred. Minimum of 10 years of industry experience, with the majority in CMC Regulatory Affairs or related roles. Experience with global early and late-phase submissions (IND/IMPD, NDA/MAA, amendments, annual reports) and health authority interactions. Prior small molecule experience preferred. Excellent knowledge of FDA, EMA, and ICH guidelines and regulations. Strong collaboration and communication skills across all levels and functions. Ability to manage multiple assignments in a fast-paced environment. Compensation
Exact compensation may vary based on skills, experience, and location. Pay range: $238,000 - $310,000 USD
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