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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements for New Drug Application for drugs and/or biologics Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products. Exposure in Global clinical trial applications or India-specific clinical trial application will be an advantage. Post approval compliances for Global clinical trials including Protocol amendment submissions, amendments in Investigator s brochure, IMPD, Investigators, addition of site(s) etc Post approval compliances for New Drugs including PSUR submissions, CMC variation submissions etc Registration certificate (RC) application and Import licence (IL) applications including variations like shelf-life amendment, storage conditions amendment and all similar CMC variations including renewals of RC/IL, where approval/notification is required to the Indian HA A good expertise on the HA portal SUGAM. Understanding of how to navigate in SUGAM for various submissions is essential. Identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. Analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. Maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.Minimum requirements What You ll bring to the role : Bachelors/ Master s Degree in Pharmacy and around 2-4 years of experience in Pharmaceutical Industry Accountability, Ability to work within timelines and excellent Knowledge of Regulatory guidelines for the areas mentioned Organizational awareness and experience working cross-functionally and in global teams will be an added advantage Excellent communication and articulation skills High-level understanding of Regulatory quality, standards and policies. Attention to detail and quality focused Team-minded,
Keyskills :
miscustomer relationsregulatory affairsnew drug applicationdeliverycareer opportunitiescustomer serviceclinical trialssalesglobal teams