5 - 8 years

7 - 10 Lacs

Hyderabad

Work from Office

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management . Key Responsibilities Include: Generate and execute of global and country-specific regulatory strategies Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop global dossiers for CMC content for initial submissions, variations and amendments Support change management activities Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment Knowledge and Skills CMC- specific regulatory knowledge & experience Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

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Faculty - Drug Regulatory Affairs - Visiting Faculty - Remote Cliniminds

10 - 15 years

15 - 25 Lacs

Noida

Remote

Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions

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Drug Regulatory Affairs Executive Sunways Bio-science Llp

3 - 8 years

3 - 5 Lacs

Gurugram

Work from Office

Preparation & Review of dossier in CTD, ACTD, ETCD format Preparation of dossiers of stability Data, Analytical method validation Preparing the SPC/SMPC as per country guidelines Preparation and Reviewing of documents COA as per the country guideline

Posted 2 months ago

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