Lubna Shaikh
Regulatory Affairs And Quality Assuranc
Mumbai
Summary
Certified Lean Six Sigma Green Belt, experienced Regulatory Affairs and Market Quality professional with a demonstrated history of working in Medical devices and Pharmaceuticals, skilled in ISO 13485 and ISO 14971 requirements, Govt Affairs and matters like Legal Meteorology, BIS registrations and MDR regulations for Indian Subcontinent region. Armed with rich experience in Medical devices and Pharmaceuticals. Expert in Regulatory, QMS and Project Management activities. Cross-functional collaborations to achieve key deliverables and to ensure compliance. Networking with Industry associations, liaison with regulatory authorities for public policy/government affairs.
Overview
2
2
years of professional experience
Work History
ADVANCED STERILIZATION
PRODUCTS INDIA PVT LTD
- Set up short-term and long-term Regulatory strategy and efficiently implement the strategies to ensure successful market access of new products, transitioning/ maintaining/ updating the existing licenses/approvals, and regulatory compliance in Greater India region
- Establishes and implements local procedures to ensure regulatory submissions, approvals are the most efficient per regulation requirements and international guidance where applicable
- Support to develop, initiate, and revise procedures to regulatory affairs to ensure compliance to the medical device and applicable products and company policy
- Support the team to collect, monitor, analyze and interpret product relevant regulations, industrial standards, national standards professionally
- Support to and communicate with internal stakeholders for business growth of assigned projects
- Monitor new and revised regulatory requirements, proactively influences local authorities on relevant regulations, guidance, and standards, timely analyze and communicate new/changes of the requirements
- Support to audit, post market surveillance activities from regulatory perspective
- Provide support to the India local made product from regulatory perspective for India local selling as well as the exportation to markets covered by India along with registrations if requested
- Review and approve the promotional materials based on the local healthcare authority requirements and involving relevant stakeholders for review when applicable
- Represent the company to interact with regulatory bodies as appropriate; may direct interaction with regulatory agencies on defined matters for India
- Market Quality responsibilities:
- Implementation and maintaining the Quality Management System (QMS) and ensure the overall effectiveness of the system within the respective region such as quality systems training, internal audits, nonconformances, corrective and preventive action, records management, field actions, supplier quality management, procurement, servicing, distribution, and post market surveillance
- Participates and hosts internal and external audits, serve as a liaison between local health authority and the business
- Maintains a comprehensive audit readiness program to ensure internal and external quality compliance
- Follow up and coordinate with cross functional team on post auditing activities and drive CAPA activities till closure
- Track on quality compliance metrics, identify, analyze gap, recommend initiatives for continuous improvement and compliance enforcement
- Responsible for processes such as maintenance of distribution records, complaint handling, maintenance and service agreements, field actions, AE reporting, and reporting changes to local authority, etc
- Support on post market surveillances activities on a timely manner not limited to Field Action, Recall or Adverse Event reporting
- Support on change control, deviation where applicable
- Maintains quality oversight of local distribution and warehouse management process (assessment, qualification, monitoring, product release) and support cross functional product release activities at the regional distribution centers as required including inspection and over labeling/rework
- Maintain quality oversight of any local required establishment licenses, or QMS certifications
- Maintain local supplier/vendor selection, qualification, and audits
- Maintain quality records and adherence to records retention policies and procedures
- Maintain quality oversight of field service processes/procedures
- Maintain quality training program with respect to quality system elements
- Establish corrective and preventive actions to mitigate potential or actual noncompliance risks
- Assesses product quality issues and escalates to upper management through established processes
- Support / lead activities, projects, and initiatives to integrate information from compliance audits and assessments and regulatory trends
- Ensure applicable relevant internal standards and processes across the business without compromising customer expectations
- Support and conduct audits activities as applicable including internal, suppliers (not limiting to DC/3PLs), external and distributor.
SMITHS MEDICAL INDIA PVT. LTD
- Develop and execute regulatory plans for product registrations, reports or correspondence with the Regulatory authorities
- Formulate or Implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Communicate regulatory information to stake holders and ensure that information is interpreted correctly
- Implement/monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary
- Oversee documentation efforts to ensure compliance with domestic and international regulations
- Review all regulatory agency submissions materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes
- Represent organization before domestic or international regulatory agencies on major policy matters or decisions regarding company products
- Develop relationship with state or federal environmental regulatory agencies to learn and analyze potential impacts of proposed environmental policy regulations
- Pharmaceutical companies (CHARAK, ELDER AND NEISS LABS)
- Registration of Pharmaceutical products in African, SEA, GCC, CIS and LATAM markets
- Critical assessment of data received from Analytical Development Laboratory, Formulation & Development, Quality Assurance, and Product Manufacturing & Quality Control Departments
- Reviewing of labeling, product monographs, artworks and other marketing/promotional materials
- Co-ordination with the International clients, the in house IBD team and the QA/QC teams for documents, samples and other regulatory requisite
- Assisting the Production, QA/QC teams in manufacturing site and/or product transfers
- Maintaining and tracking timeline of submissions, responses and registration database and archival of critical database
- Management reporting on number of Registration Applications submitted & approvals received on monthly basis
Regulatory Affairs Specialist
Biomet Orthopaedic India Pvt Ltd
12.2012 - 07.2014
- Registration of Medical Devices with the Central Drugs Standard Control Organization
- Reviewing and Compilation of the Dossiers for Regulatory submission as per CDSCO guidelines
- Follow ups on the Regulatory applications with the Drug Inspectors at CDSCO office thereby maintaining the absolute regulatory database
- Responding with apt technical data/documents on the Queries raised by CDSCO related to the registration of Orthopaedic Implants/Medical Devices
- Maintaining and tracking timeline of submissions, responses and registration database and archival of critical database
- Co-ordination with global regulatory counterparts for technical, quality & compliance during and after regulatory approvals
- Communicating the changes/updates in the Indian regulatory environment of Medical Devices with the International Regulatory Team
- Providing documentation support for the In-house Audits and Inspections
- Management reporting on number of Registration Applications submitted and approvals received on monthly basis
Education
Certified Lean Six Sigma Green Belt Certified Quality Management Systems Auditor/Lead Auditor (ISO 13485:2016) (PR350) Certified ISO 14971:2019 Risk Management for Medical Devices -
Post Graduate Diploma - Pharma Management
University of Mumbai
BSc. - Chemistry
University of Mumbai
H.S.C - undefined
University of Mumbai
S.S.C - undefined
Maharashtra State Board
Skills
Risk management
Regulatory Policies
Audits
Strategic
Project Management
Timeline
Regulatory Affairs Specialist
Biomet Orthopaedic India Pvt Ltd
12.2012 - 07.2014
ADVANCED STERILIZATION
PRODUCTS INDIA PVT LTD
SMITHS MEDICAL INDIA PVT. LTD
Certified Lean Six Sigma Green Belt Certified Quality Management Systems Auditor/Lead Auditor (ISO 13485:2016) (PR350) Certified ISO 14971:2019 Risk Management for Medical Devices -
Post Graduate Diploma - Pharma Management
University of Mumbai
BSc. - Chemistry
University of Mumbai
H.S.C - undefined
University of Mumbai
S.S.C - undefined
Maharashtra State Board