CMC and Labeling US Market

Min 6yrs of experince in Regulatory affairs, CMC.US market exp mustlocation Bachupally, Hyderabad

SummaryResponsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC) . Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.About the RoleMajor...

Your Key Responsibilities:Your responsibilities include, but not limited to:Performs tasks assigned as per applicable procedures (e.g., GOPs, SOPs, WIs) This includes, but is not limited to:CDS and core English SmPC/PIL/Label (in line with CDS and all relevant HA signals) preparation and maintenanceSignal Detection & Evaluation: perform external signal...

About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about...

Principal CMC Statistician Career CategoryQuality Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight...

Join Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic...

Career CategoryQualityJob DescriptionJoin Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases....

DescriptionAt USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research...

Job Description:Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated...

Career CategoryRegulatoryJob Description Job Description:Amgen is a leading human therapeutics company in the biotechnology industry.  For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine.  As a Fortune 500 company serving millions of patients, Amgen continues to be an...