Regulatory Affairs
Julphar
Total des années d'expérience :17 years, 5 Mois
Key Responsible Area:
• Maintain documented regulatory project plans in line with best practice recommendations.
• Update functional leads and maintain transparency of information across regulatory function.
• Regulatory support deviation and change control activities at as appropriate.
• Manage the regulatory submission including management and coordination of the preparation of all regulatory documentations at different Regulatory milestones.
• Liaising with, and making presentations to regulatory authorities.
• Supports operations by supervising staff, planning, organizing, and implementing.
• Assist in the registration process of drugs and devices.
• Responsible for life cycle management of submitted DMF’s and ensure that the regulatory/ customer commitments are rally.
• Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to.
• Developing and writing clear arguments and explanations for new product licenses and license renewals.
• Providing strategic advice to senior management throughout the development of a new product.
• Reviewing company practices and providing advice on changes to systems.
• Specifying storage, labeling and packaging requirements.
• Preparation, review and submission of drug substance dossiers to EDQM, few European countries, Canada, Australia and Singapore in CTD format.
• Preparation, review and submission of open parts and amendments to customers.
• Preparations and review of DMFs in all types of submissions procedure like paper submission, e-CTD and NeeS formats as respective guidelines.
• Preparation of Notifications and Annual Reports for drug substances.
• Responsible to discuss with authorities / customers to track the submission and resolve any issues during the assessment of DMF’s.
• Responsible to prepare the customer queries responses on submitted DMF’s and submit to customers.
• Responsible for life cycle management of submitted DMF’s and ensure that the regulatory/ customer commitments are rally.
• Review of documents such as Process Development report, batch manufacturing records, stability protocols, specifications, analytical method validation and process Validation reports for regulatory compliance.
• Involvement in various day to day quality and regulatory activities to improve the company systems and to develop knowledge with respect to current guidelines and regulatory requirements.
• Responsible for preparation of protocols and reports for process validation and Annual Product Review.
• Responsible for the preparation and submission of Manufacturing License applications, COPP Certificates, NOC applications, Free Sale Certificates, General GMP certification, Certified Technical Staff applications and all other communications to statutory bodies.
• Self-inspection and monitoring in Production, Ware House and Quality units.
• To review the analytical test reports, compiling and updating Quality trend data.
• Responsible for review of batch production record (BPR) for compliance against standards.
• Responsible for preparation of protocols and reports for process validation.
• Responsible for stability initiation & planning related to sterile manufacturing.
• To co-ordinate with Regulatory Affairs requirement for filling documents and its compliance related sterile manufacturing.
• Review of raw material Vendor CoA’s related sterile manufacturing.
• Responsible maintaining of calibration schedule, master layouts for sterile manufacturing, purified water system and microbiology laboratory.
• Responsible for customer requirement related to sterile products and maintaining the retention samples.
• Prepare Certificate of Analysis, Update the dispatch and label reconciliation logbooks.
• To review the analytical results in the SAP and approval of the product
• Inspection and analyze the sample in Oil, Gas & chemicals section.
• Inspection of terminals (petroleum) in Hyderabad region, India.
• Distribution of marker to terminals (petroleum) throughout Andhra Pradesh and Telangana, India.
• Daily repot updating related to no. of terminals & no. of Retail outlets inspected and quantity of marker distributed to terminals.
• Preparation of monthly report related to no. of terminals & no. of Retail outlets inspected and quantity of marker distributed to terminals.
• Inspection of export consignments
• To review the analytical results in the SAP and approval of the product.
✓ Intermediate (M.P.C) from Loyola Jr. College, Karimnagar in 2000.
✓ S.S.C from Maharshi New wings High School, Karimnagar in 1998.