Manage overall function of Regulatory Affairs & Quality Department and Lead role in obtaining Approvals.Manage & supervise the compilation, review, and processing of regulatory submissions (CTAs, BENOC, MAA) for Biologics, NCEs, FDCs and Medical Devices to DCGI, ASEAN, GCC and SAARC countries.Liaison: Health Authorities DCGI’s office; ADC (CDSCO) Cargo & State LA, National Institute of Biologicals (NIB), CDTLs; & Customers. Cancellation of Letter of Guarantee.DCGI & SLA: Compilation and submission of CT and M&M Application in Form-44, Re-registrations. Submission of AEs, SAEs, PSURs and PMS etc. Product Defense; Presentations for New Drug Approvals; Clinical Trials; PMS; PAC etc to SEC Experts/DCGI.Obtaining Form-45, RC (Form-41), Import Licenses (Form-10), and Re-registrations. Non-Conviction Certificate, Import & Marketing Certificate, Manufacture and Marketing certificate (MMC applications) etc. Respond to queries, Regulatory Support for Institutional/Government (tender) business.Post approval changes: Extension of Shelf life; Mfg Process; Addition of Mfg. Site/Presentation, etc.Clinical: Review of CT protocols, Reports; PSURs; SmPC. Obtaining NoC for PMS.Product Labeling: In-charge of developing, review & approval of artworks (label, carton, PIL)

Reviewing source documents for its regulatory adequacy and preparing scoping report before implementation in the dossiers. Technical review of Quality, Safety and Efficacy aspects of generic drug dossiers.Submitting applications in NeeS format with adequate planning, compilation, execution, review and ensuring timely submission.Providing continual updates ensuring the compliance with current pharmacopoeia and regulatory requirements respectively and playing a key role in ensuring regulatory compliance such as setting specifications, packaging & storage, retest etc.Review of documents and compilation of quality dossier as per CTD, NeeS, ACTD and regional formats for different dosage forms.Preparation and submission of CTD Module (I to V) for Market Authorization Application.Developing & updating the packaging materials (Labels, Carton, Pack Inserts & Visual aids): Creating PIL/PI/PFU and SmPCs for generic drug submissions for different markets.Maintaining data base of regulatory/technical information, products registered, re-registration deadlines etc.Coordinating, communicating and liaising with the agency officials.Preparation and submission of Clinical Trial Application for Phase (I - IV), BE-NOC applications, Import and Export Application to the HA.Notification and submission of any amendments or Post Approval Compliance activities to the HA.Medical writing:Non clinical and clinical overviews and summaries for generic filing in USA, EMEA and Emerging markets.Product Labeling: Compilation and review of Product label, PIL, IMPDs and SmPCs.Therapeutic rationales, safety and efficacy data for FDCs, scientific justifications for waiver of CT studies, presentation for SEC meetings.GxP Audits:Relevant experience in conducting GCP, GLP, NABL & NABH audits, due diligence inspectionSetting up Quality Management System in GxP facilities.

Reviewing source documents for its regulatory adequacy and preparing scoping report before implementation in the dossiers. Technical review of Quality, Safety and Efficacy aspects of generic drug dossiers.Submitting applications in NeeS format with adequate planning, compilation, execution, review and ensuring timely submission.Providing continual updates ensuring the compliance with current pharmacopoeia and regulatory requirements respectively and playing a key role in ensuring regulatory compliance such as setting specifications, packaging & storage, retest etc.Review of documents and compilation of quality dossier as per CTD, NeeS, ACTD and regional formats for different dosage forms.Preparation and submission of CTD Module (I to V) for Market Authorization Application.Developing & updating the packaging materials (Labels, Carton, Pack Inserts & Visual aids): Creating PIL/PI/PFU and SmPCs for generic drug submissions for different markets.Maintaining data base of regulatory/technical information, products registered, re-registration deadlines etc.Coordinating, communicating and liaising with the agency officials.Preparation and submission of Clinical Trial Application for Phase (I - IV), BE-NOC applications, Import and Export Application to the HA.Notification and submission of any amendments or Post Approval Compliance activities to the HA.

Reviewing source documents for its regulatory adequacy and preparing scoping report before implementation in the dossiers. Technical review of Quality, Safety and Efficacy aspects of generic drug dossiers.Submitting applications in NeeS format with adequate planning, compilation, execution, review and ensuring timely submission.Providing continual updates ensuring the compliance with current pharmacopoeia and regulatory requirements respectively and playing a key role in ensuring regulatory compliance such as setting specifications, packaging & storage, retest etc.Review of documents and compilation of quality dossier as per CTD, NeeS, ACTD and regional formats for different dosage forms.Preparation and submission of CTD Module (I to V) for Market Authorization Application.Developing & updating the packaging materials (Labels, Carton, Pack Inserts & Visual aids): Creating PIL/PI/PFU and SmPCs for generic drug submissions for different markets.Maintaining data base of regulatory/technical information, products registered, re-registration deadlines etc.Coordinating, communicating and liaising with the agency officials.Preparation and submission of Clinical Trial Application for Phase (I - IV), BE-NOC applications, Import and Export Application to the HA.Notification and submission of any amendments or Post Approval Compliance activities to the HA.

Prioritize level of care based on critical needs.Participating in interdisciplinary patient care rounds and communicate follow-up with clinical team.Prevent, detect, and resolve medication-related problems and to make appropriate evidence-based, patient-centered medication therapy recommendations as part of the interdisciplinary team.Determine and resolve any medication therapy problems including drugs without indications, medical conditions for which no therapy is prescribed, therapy inappropriate for medical condition, incomplete immunization record, inappropriate dose, dosage form, duration, schedule, route of administration,method of administration, therapeutic duplication, medication allergies, and clinically significant drug drug, drug-disease, drug-nutrient, or drug-laboratory test interactions.Effectively verify patient medication orders for appropriateness and accuracy.Appropriately document clinical interventions.Provide concise, applicable, comprehensive, and timely responses to requests for drug information from patients and health care providers.Actively participates in the development and implementation of performance/quality improvement and patient safety activities for clinical service area, Pharmacy, and Medical Center.Identify potential technical or patient care issues and work with Clinical Coordinator to make recommendations to avoid issues.Communicates effectively with patient care areas and pharmacy staff/managers.Report medication errors and adverse drug reactions.Participating with Clinical Coordinator, clinical team and the Pharmacy department to evaluate and measure the impact of new approaches that have been implemented.Participating in clinical guideline development, critical pathways, disease management, and drug use programs.Participating with Clinical Coordinator to identify high-cost and high-use agents within defined area of practice and participates in financial management initiatives.

Hospital Pharmacist:Receiving of goods from various suppliers, arranging the received goods to the respective rack. Issuing the drugs based on ward indent or prescription from customers. Dispensing of medications with clear instructions and correct labeling to patient upon approval by the Manager of Pharmacy Services.Supply and labeling of all drugs issued to nursing units.Entering medication orders into dispensing program accurately and utilizing software correctly.Stock processing-receiving, checking, unpacking, putting away, displaying.Dispatching drugs to nursing units with proper care and security during transit. Recording requisitions accurately.Performing quality control monitoring in pharmacy and nursing units on schedule as assigned.Preparing purchase orders for approval. Processing invoices and maintaining price updates.Compiling with standard operating procedures for storage, recording and requisitions of drugs.Clinical Research coordinator:Maintenance of Investigator Trial File (ITF), ethical practices at trial site, coordination with subjects.Responsible for proper filing of case records, data input for eCRF.Maintaining Informed Consent Documents and reviewing query language and narratives.Responsible for timely notification to Ethics Committee.Efficiently handling logistic supply of drugs and dissemination to subjects.Verifying subject safety and adherence to FDA Regulations and ICH, GCP guidelines.Vigilant regarding adherence to Schedule Y guidelines on EC SOP, and Trial site SOP.Ensuring Adverse Events are timely and efficiently reported.Responsible for further follow-up activities from sponsor’s side.Working directly with CRA assisting monitoring and close-out visits.Data compilation and statistical analysis.Coordinating current project through effective communication between trial subjects and investigators.Formatting, editing CRFs; verification of raw data with electronic CRFs.Consent form verification.

Establishing adequate measurements to monitor areas performance and participating in the control and auditing of manufacturing and packaging operations to assure conformance of products.Managing the Quality Assurance areas and staff to achieve effective and efficient operations and communicating control policies, cGMP regulations and requirements to Quality Assurance, manufacturing and packaging personnel.Conducting audits of Manufacturing and Packaging Records and QA process related documents to assure that documentation is free of errors and complies with GMP’s and SOP’s.Initiating or revising department SOP’s in order to comply with quality standards. Reviewing and approving SOP’s as required.Reviewing existing control/manufacturing operations and providing innovation of more effective/efficient techniques.Ensuring that Quality Assurance area goals and objectives can be accomplished in a timely manner, Providing a positive, highly professional environment that can promote open communication, creativity and continuous improvement attitudes; Enforcing safety rules and attitudes to promote a healthy environment.Selecting, training and evaluating the performance of personnel.Recommending compensation changes in a timely manner. Planning and providing developmental opportunities for personnel in both technical and management areas to increase productivity and encourage job satisfaction.Reviewing and approving Quality Assurance and production investigation reports as required. Evaluating investigation reports and all related documentation for compliance with GMP’s, SOP’s and pharmaceutical regulations.