CMC Regulatory Specialist

Job Summary: -Regulatory professionals who specialize in chemistry, manufacturing, and control (CMC) activities prepare and publish regulatory documentation for submissions to health authorities.This involves interacting with these authorities on CMC-related questions to support the launch of new products or existing ones.Key Responsibilities: Develop a...

Regulatory Activities ManagerThis role is responsible for overseeing regulatory activities related to chemistry, manufacturing, and control (CMC) of products. Key tasks include preparing and publishing CMC documentation for submissions to Health Authorities, as well as interacting with HA's on CMC questions to support new product or post-marketed launches.

Job Summary:-Regulatory professionals who specialize in chemistry, manufacturing, and control (CMC) activities prepare and publish regulatory documentation for submissions to health authorities. This involves interacting with these authorities on CMC-related questions to support the launch of new products or existing ones.Key Responsibilities:Develop a...

Regulatory CMC ProfessionalWe are seeking a highly skilled Regulatory CMC Professional to join our team.Key Responsibilities:Prepare and publish REG CMC documentation for submissions to Health AuthoritiesInteract with Health Authorities on REG CMC questions to support new product or post-marketed launchesThe ideal candidate will have strong knowledge of...

About Our CMC Regulatory Role:Seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to lead global CMC submission activities.Develop and implement strategic plans for global CMC regulatory submissions.Lead and manage global CMC submission projects.Author high-quality CMC documentation for health authority submissions.Ensure...

Job Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have...

Job Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team.This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities.The ideal candidate will have...

Job Title: Chemistry, Manufacturing and Control Regulatory Expert-We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have...

Job Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have...

Regulatory Affairs Expertise for CMC SubmissionsIn this role, you will lead and manage key activities related to CMC regulatory submissions for USFDA purposes. This includes preparing, reviewing, and filing ANDA documents. You will also oversee the compilation and submission of Annual Reports, amendments, and deficiency responses.You will work closely with...