Executive/Assistant Manager/ Deputy Manager - RA(Canada Market) Eugia Pharma Specialities

2.0 - 7.0 years

5 - 13 Lacs

Hyderabad

Work from Office

Role & responsibilities: : Experience in Canada Market Dossier compilation (Injectable & OSD dosage forms) & knowledge of regulatory procedures and guidelines (ICH). Planning, execution and assessment of product life cycle management activities and strategies (LCM & Variation) Review technical documents like Protocols, API & Drug product technical packages, Change Controls etc and prepare technical documents to support regulatory submissions Knowledge in query response to agencys questions within assigned timelines ** Canteen & Transportation Facilities are Provided

Posted 12 hours ago

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Sailpoint Developer Conviction Hr

5.0 - 10.0 years

8 - 18 Lacs

Noida, Hyderabad, Bengaluru

Work from Office

Java, Bean Shell, JDBC, XML,Web services Excellent Knowledge on Sailpoint IIQ Fundamentals.Custom Connectors,Connector Integration Architecture, Lifecycle Manager LCM Configuration .Very good understanding of Identity and Access Management Lifecycle.

Posted 1 month ago

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Regulatory Affairs Specialist Sun Pharma

5.0 - 10.0 years

6 - 16 Lacs

Gurugram

Hybrid

Role & responsibilities Job Summary : Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations : a. Prepare and review variation , Annual notification and labelling approval for US and OAM b. Review of change control and file variation as per country requirement 4. Regulatory compliance: a. eCTD compilation b. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc Note:- We are specifically looking for professionals with prior experience in US/EU Market.

Posted 1 month ago

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Sailpoint Iiq Developer Overseas Information

6 - 11 years

16 - 22 Lacs

Hyderabad, Pune, Bengaluru

Hybrid

Hello Jobseekers.. I am Hiring now Sailpoint IIQ Developer for one of my clients.. Location: Pan India ExperieExperiencenece: 6-13 Years NP: Immediate-45 days JD: Should have experience in SailPoint IIQ, including Life Cycle Manager LCM Experience with the following programming languages. Java BeanShell JavaScript Angular JS JSP Servlets Configure and Deploy SailPoint IIQ Connectors for various target systems e g AD Exchange Databases Servers Mainframes and Applications. Experience in one or more of the following identity governance areas User Provisioning Access Certifications Access Request Workflow Delegated Administration Password Self Service Knowledge of Active Directory LDAP Azure AWS. Experience in developing custom connectors in SailPoint IIQ. Experience in configuring custom reports in IIQ. Experience with Database threads and Session Management Design and implement system features based on customer requirements Work with team on designs code reviews and testing based on customer processes. Experience in documenting User guides and training material to support development deployments tasks. Familiarity with the Software Development Life Cycle SDLC On Shore Country Region details of the Project NA. To apply, send me your resume at chanchal@oitinida.com

Posted 2 months ago

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