Regulatory Submissions

Job Title: Regulatory Global Submission ManagerKey ResponsibilitiesIn close collaboration with Regulatory Asset Oversight, GRL and RMT, provides project management support at submission level, drives execution of agreed plans and ensures timely and compliant delivery of submissions for US, EU and Rest of the World (ROW) markets.Outlines content deliverables,...

Core Job Responsibilities: Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA Prepare and submit...

Looking for AGM - Strategy & AOP for one of the Client based in Goa.Co-develop cross functional strategic initiatives along with measures and targets.Prepare detailed AOP for the business based on inputs provided by the departments.Finalize Balanced Scorecard for the business and departments Goals ensuring alignmentPrepare and release a set of MIS to...

**Division**: - Quality**Department**: - Quality**Employment Type**: - Permanent**Job Purpose**: Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines **Accountabilities**: I. Collate, review and provide required work plans on received...

**Division**: - Quality**Department**: - Quality**Employment Type**: - Permanent**Job Purpose**: Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines **Accountabilities**: I. Collate, review and provide required work plans on received...

Key ResponsibilitiesReview and verify accompanying documentation for regulatory samples received from authorities. Coordinate with officials for any clarifications required.Categorize samples upon receipt and assign relevant testing parameters in accordance with FSSR, surveillance plans, or specific instructions from regulatory bodies.Ensure that all testing...

Job Title: Regulatory Associate Manager - Product Variations, CD CMCBusiness IntroductionAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge...

Job Summary : To ensure the safety and security of passengers, staff, and airport facilities by enforcing aviation security regulations, monitoring restricted areas, and responding to security incidents. Key Responsibilities: Maintain security standards as per Company requirements,Ensure effective threat assessment and response capability.Achieve...

• Assist in establishing the framework for risk management activities • Identify credit risk; assess company effectiveness in managing these risks through appropriate internal controls; and build awareness of the business implications of credit risk, and how to manage credit risk. • Asist in development of risk assessment tools and procedures •...

Business IntroductionAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture...