Pune Biotech Senior Executive Regulatory Affairs MH

Job description

Review of CMC related documents received from various inter functional departments and provide necessary inputs as per regulatory requirements. Preparation of CMC sections, compilation and review of dossiers as per country specific requirements. Track collection of all dossier/information from all concerned departments and ensure submission to regulatory authorities as per the agreed timeframe. Preparation and compilation of query responses by coordinating with inter-function teams and submit to regulatory authorities within stipulated timeline. Coordination with inter departments (QA, QC, R&D, MSAT etc.) for source documents required for various regulatory submissions. · Preparation and maintenance of product specific TRACKERS. · Continually track any changes, variations or process modifications throughout product life cycle and carry out necessary update to documentation in order to comply with all norms. The above list is not exhaustive and may be assigned additional responsibilities from time to time. In the absence, the above Job Responsibilities shall be done by competent / trained personnel from team. Education Masters in Biotechnology or Biotechnology Post Graduation in Pharmacy or Pharmacy Competencies Apply now » Apply Now Start applying with LinkedIn Please wait... Find similar jobs: Multicare-Philippines, Lupin-India Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. Required Cookies These cookies are required to use this website and can't be turned off. Required Cookies Required Cookies Provider Description Enabled SAP as service provider We use the following session cookies, which are all required to enable the website to function: "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data center "JSESSIONID" is placed on the visitor's device during the session so the server can identify the visitor "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another Cookies from provider SAPasserviceprovider are required and cannot be turned off Advertising Cookies These cookies serve ads that are relevant to your interests. You may freely choose to accept or decline these cookies at any time. Note that certain functionality that these third parties make available may be impacted if you do not accept these cookies. Consent to all Advertising Cookies Advertising Cookies Provider Description Enabled LinkedIn LinkedIn is an employment-oriented social networking service. We use the Apply with LinkedIn feature to allow you to apply for jobs using your LinkedIn profile. Opting out of LinkedIn cookies will disable your ability to use Apply with LinkedIn. Cookie Policy Cookie Table Privacy Policy Terms and Conditions Consent to cookies from provider LinkedIn