Hire the Best Regulatory Affairs Specialist in Hyderabad, India

Regulatory Document Specialist/ publisher at Tata Consultancy Services

Working as Regulatory Affairs officer A challenging and interesting work.

To work in a challenging environment that provides generous opportunities for learning so as to make best use of my knowledge and skills towards the growth and development of the organization. Presently part of the team involved in assessment and mitigation of Nitrosamine risk in drug products..

A highly motivated Quality Engineer with an experience of establishing risk management files, technical documentation and Post market surveillance reports((PMSR/PSUR) for medical devices. Skills: ISO 14971-Risk management, EU MDR Technical documentation, Post market surveillance, Labeling Remediation, Internal Audit-ISO13485 and Engineering change management

Remediation of medical device documents from MDD to MDR, creation of documents for the new regulations as per the MDR, Clinical Evaluation Report, Post market surveillance, vigilance system,Risk Management, Materials memo, Bio compactability report, Design stage documents - Design Input, Design output, Design development plan, Design verification and Validation, Design Review, Design Transfer, Design changes, Technical Documentation, Risk Management, Labelling. QMS implementation and remediation as per ISO 13485, EN ISO 13485 & EU MDR Management activities - Estimation, Project Planning, SOW Preparation. Well knowledge in Product life cycle Management (Siemens Teamcenter(TcU) , ARAS, JDE, ERP, BOM Structuring, Specification Standardization, Design Parameter analysis. EMAIL : rneeluactive@gmail.com CONTACT : +91-8098799898

CDSCO Fillings (Indian Regulatory Submission):  Dossier preparation for NOCs of BA/BE Studies, PK/PD studies of Biologicals (Insulin Preparations) and SND applications, Import Licenses and Post Approval Changes (Amendments) to CDSCO  Filling of bioequivalence study applications, clinical trials - phase I, II & III application, Import Licenses and SND applications through SUGAM Online Portal  Preparation of presentation and executive summary for SEC meetings  CTRI registration of clinical studies  Handling of Regulatory Query Responses  Keeping track of the new draft regulations and update the cross functional team about the same  Coordination with formulation team for documents required for filling of NOC applications as per Indian Regulatory requirement. Medical Writing:  Preparation of BA/BE, PK/PD study Protocols for healthy volunteers and patients studies (In-house & Outsourced studies) for various dosage forms i.e. Oral solid, Oral liquid, Injectable, Inhalers, Nasal Sprays, Trans-dermal Patches etc.  Collaboration with stakeholders: Biostatistics, Formulation Dept., and Principal Investigators while interpretation of PK study results, study designing, PK sampling time points and Subjects Safety concerns.  Preparation of Clinical Study Reports  Preparation of English Informed Consent Forms (ICF) and review and verification of Marathi and Hindi ICFs.  Preparation of CTD inclusive of Module 2.5 (Clinical overview) and Module 2.7 (Clinical summary) for obtaining marketing authorization of pharmaceuticals in European region.  Preparation of Risk Management Plan (RMP) for EU submission and Risk Evaluation and Mitigations strategies (REMS)  Preparation and review of in-house Standard Operating Procedure (SOP) Member Secretary of Aurangabad Committee for Ethics (ACE) Project Management and study co-ordination:  Project planning, execution of in house as well as patient studies in different hospitals  Strategic planning of EU submission studies (Feasibility check of studies)  Training to the staff on guidelines and regulatory updates on time to time (Knowledge Sharing Session)

Clinical Regulatory Document Formatting, Processing, Compilation and Publishing of Clinical Study Reports, Protocols, Protocol Amendments, Post Marketing Safety Reports like PSUR, PADER and Other Related Reports Using ISI Publisher and docuBridge. Publishing Various Labeling Documents Like Label Justification Documents, CCRMDS, SmPCs, PILs, Clinical Overviews, and Addendum to Clinical Overviews, Expert CV, Expert Signature and Clinical Expert Statements. Make the PDF Documents E-submission Ready Using ISI Tool box. Format the Clinical Documents in MS-Word as per Standard Guidelines. Processing CMC Documents and iCTD to aCTD Conversions. Import the Templates and Documents in Document Management System - ERIS and CONNECT. QC of Published Documents for Compliance With Electronic Submission Requirements Ensure That Documents are Processed and Issued in Accordance With Timelines. Identify and aid in implementation of new activities by formulating the process map and imparting training, designing a quality plan for the process Provide support in transition of activities especially at the early stages of the project Provide support in creation of process specific documents e.g. Work instructions, etc. Provide feedback to business on the feasibility of new requirements and suggest to them methods to improve the current processes and implement solutions for problems in critical areas Present process loopholes and areas of improvement using domain experience Conduct knowledge sharing gatherings within process and participate in learning sessions Mentor and coach new hires and the team on the processes and functionalities Sign-off new trainers Conduct periodic reviews of processes to evaluate the team quality and provide solutions for improvement, outline critical-to-quality steps to help the team define their quality Conduct the quality check of the activities performed by the team and provide feedback to the associates on the basis of the findings

 Preparation and review of Drug master file as per current guidelines of respective regulatory authorities & making regulatory strategy for registration.  Ensures regulatory compliance by effectively communicating requirements and guidelines, facilitating timely and complete regulatory submissions. Tracking record of supporting documents.  Responsible to prepare, assemble, review, and/or evaluate CTD format to US, EU, Canada, ROW, (amendments, notification, annual reports, biannual updates and additional documentation, as needed) in an efficient and timely manner and defining requirements of product development and lifecycle management.  Responsible for preparation of deficiency response for various regulatory agencies during new DMF assessments as well as amendments.  Interacts with respective team members in other departments, other R&D functions and other Regulatory Affairs functions to deliver customized high quality regions/countries specific dossiers, documents & materials to affiliates in accordance with business priorities  Preparation and review of CEP dossier.  Responsible for reviewing acceptability of documents for submission (CMC vendor documents, specifications, test procedures, process validations, manufacturing process development reports, manufacturing batch records, critical process parameters, structural elucidation, impurity profile, container closure system including product label, stability protocols, stability summary sheets etc) and communicating with other departments and external vendors and partners with goal of achieving shortest possible time from project inception to product launch and assure submission timelines are met.  Reviewing the change controls and assessing the potential impact on the regulatory submissions where applicable and define the strategy to notifying the customers. Making strategy for filing changes and providing requirements to concern departments for filing the changes to regulatory agencies.