Quality Assurance Control

R E S U M E

Y.VIJAYALAKSHMI

****, ****** **-*, ***** Colony, Gurgaon (NCR – Delhi),India

Mobile : +91-961*******,989*******

E-mail : ************@*****.***

Profile

• Result-oriented M.Pharm.(BITS) professional with significant experience and proven track record.

• Performance-driven professional with 18 years of continuous advancement and expertise in Global Regulatory Affairs.

• Strong leader with unsurpassed interpersonal skills.

• Enthusiastic communicator with proven analytical skills.

• Computer-literate performer with technical proficiency covering wide range of applications.

Work Experience :

23 May 2011 –till date

August 2010- May 2011

Associate Director (Head)– Regulatory Affairs for Branded Generics (ASIAPAC/LATAM/CEEMEA/EU countries) of Pharmaceutical products.

AstraZeneca India Pvt. Ltd.

Ensure timely submission of the high quality drug product dossiers of tablets, capsules and Injections in the above said countries and submission of the corresponding response to queries to achieve timely approval

Responsible to support for India Launches wrt art works & product information

Responsible to develop and implement the regulatory strategies to get earliest approvals there by ensuring day1/timely launches.

Responsible to drive the cross functional issues.

Responsible to manage the challenges between the vendors (external personnel) and marketing companies (internal personnel)

Guide vendors wrt regulatory requirements during the development of the products.

Actively participate in the leadership team meetings (different management levels are the participants) to provide innovative ideas to work differently, solutions to the problems/operational issues, providing updates of different projects etc.

Responsible for Regulatory due diligence of new vendors

Managing the contract employees with proper monitoring of security of IT systems

Establish, monitor performance metrics for the year.

Responsible for compliance of regulatory function wrt processes, procedures and to ensure the approval packages are available to QA & manufacturing sites.

Responsible to ensure global systems are followed for Branded Generics Regulatory function

Responsible to counsel, manage & develop the regulatory team .

Responsible to manage post approval activities like variations wrt CMC & Label changes, renewals, withdrawal of MAs & PSURs etc

Responsible to maintain the data base for archiving of dossiers and submission, approval information

Responsible for managing department budget & resources etc

Regular interaction with the commercial team to understand the business needs.

Responsible to maintain the risk register for the department wrt departments operational issues which impacts filings, approvals & launches and escalate to the management on need basis and also responsible to log the high level business risks of RA function in the risk register of total RA functions.

Actively participated during the audit of the mfg sites of vendors by ANMAT, Argentina.

General Manager –Regulatory Affairs (US/EU/AUS/ROW countries/India)

Promed Exports Pvt Ltd, India

Ensure timely submission of the high quality drug product dossiers of Ophthalmic solutions and suspensions in USA in e-CTD, EU in NeES Format, Russia & CIS countries in CTD format.

Review of DMFs for filing in USA & EU

Submission of quality data/documents for response to Queries/amendments & Variations/supplements as per regional & manufacturing requirements in USA, EU, Russia and CIS countries.

Establish objectives for each of the group members, in

keeping with the goals and objectives of the department and track progress of work against these objectives. Plan strategies; guide the team members to ensure quality and timely deliveries.

Guide/effectively co-ordinate with various departments like Product development, Quality Assurance, Quality Control and Manufacturing locations etc. in working as per the regulatory requirements of various countries.

Coordinate inspection of USFDA/European Agencies / TGA for obtaining CGMP Certificates for manufacturing unit.

August 2003 - July 2010 (7 years) Group Leader (B3)- Regulatory Affairs (EU & ANZ)

Ranbaxy Laboratories Limited, India

Ensure timely submission of the high quality drug product dossiers of different dosage forms like tablets, capsules, Powder for Injections, Powder for oral suspension etc. in different formats like ICH/NEES/e-CTD for filings through National, MRP and DCP routes in European Union & ANZ countries.

• Review of data generated during development stage to finalize the documents for technology transfer dossier (TTD) & to promptly provide clear inputs to concerned departments wrt data generation as per regulatory guidelines for dossier compilation & submission.

• Ensure the compilation & timely submission of updated dossiers for national as per the current European market requirements and for MRP.

Submission of quality data/documents for response to Queries & Variations as per regional & manufacturing requirements in European Union & ANZ countries.

• Critically review query-response to satisfy agency’s requirements and to ensure fast track approvals within 12-24 months to meet the target launch.

• Consolidation and timely submission of response document & variations and to keep track of the submitted responses/variations.

• Swift follow up with concerned departments and achieve timely submission of responses for MRP and DCP queries as per the time table of MRP/DCP.

After submission of the dossiers/response to queries/variations ensure to archive the dossier/documents and enter the information into regulatory database.

Establish objectives for each of the reporting group members, in

keeping with the goals and objectives of the department as agreed with the Head of Department, and track progress of work

against these objectives. Plan strategies; guide the team members and direct reports to ensure quality and timely deliveries.

Guide/effectively co-ordinate with various departments like Product development, Quality Assurance, Quality Control and Manufacturing locations etc. in working as per the regulatory requirements of various countries.

Conduct Product Review Committee (PRC) meetings for timely availability of data for filings in various countries.

Exposure to regulatory filings in rest of the world countries like Russia & CIS, USA and some of the emerging markets.

Compliance, Harmonization and support to development/Quality.

• Review the approval packages against the submitted details with the Agencies and ensure to provide the same to QPs/manufacturing locations for timely launch of the product.

• Share the approval packages and commitments made during approval to the concerned departments to generate the data required to fulfill the commitments .

• Review and ensure adequacy of various documents like change controls, commercial Stability protocols, process validation protocols to meet the commitments of the Agency.

• Provide support for trouble shooting problems during manufacturing at the time of launch of the product or during its life cycle.

Build & Strengthen communication with Regulatory colleagues

• Co-ordinate with our regulatory colleagues working in India for US and emerging markets and also with plant regulatory colleagues.

• Co-ordinate with our regulatory colleagues working in various countries & Country Heads to facilitate an accurate and complete submissions, resulting in their approval.

Working out Regulatory Strategy

• Formulating regulatory filing strategies by literature search/business volumes and cross verification with innovators strategy through MRI index/EMEA site etc.

Training /People Development

• Ensure professional discipline in the team in alignment with the organizational Values, policies and working practices of the organization.

• Build and reinforce team-working as well as healthy interpersonal and professional relationships in the group.

• Training On e-submission, NeES, Synergy database etc.

• Guiding the team members for reviewing Literature search, Monographs, PARs etc.

• Guiding, Mentorship and knowledge up gradation of the team members through Seminars/Internet/Trainings/Discussions etc.

• Preparation and updation of the SOP’s, Systems and formats to cope up with the current regulatory requirements of various countries and day to day smooth functioning.

Self development

• Plan own day-to-day work under the broad objectives and direction laid out by the Department Head taking account of priorities to ensure maximum output of work and most efficient use of resources.

• Communicate effectively with senior scientific members, peers and team members as well as share scientific information, as a part of self-development in scientific areas. Internally network with scientists from other expertise areas.

• Make technical / scientific presentations and related to own work or related work reported in literature to peer scientific groups.

Coordinate inspection of European Agencies / TGA for obtaining CGMP Certificates for manufacturing units.

February 2001 – July 2003 Consultant – Regulatory Affairs (ROW & Europe)

Windlas Biotech Limited, India

August 1996 – July 2000 Sr.Executive – Regulatory Affairs (Russia & CIS)

Promed Exports Limited, India

August 1993 – May 1996 Senior Analytical Scientist

Dr.Reddy’s Laboratories Limited, India

Professional Qualifications

Bachelor of Pharmacy [B.Pharm(Hon.)], C.G.P.A 6.19 / 10.0 (1989-1993)

The Birla Institute of Technology & Sciences (BITS) Pilani, Rajasthan, India

M.S. in Pharmacy (M.Pharm.) C.G.P.A 7.74/10.0 (1995-97)

The Birla Institute of Technology & Sciences (BITS) Pilani, Rajasthan,India

Computer Proficiency

Familiar with Microsoft Office - Word, Excel & PowerPoint.

Web browsers (explorer & netscape), Email Lotus Notes, MS Outlook etc.

Achievements

Individual performance has been rated at 160% in AZ.

Recommended for promotion to Senior General Manager at Promed Exports Pvt. Ltd. after 6 months of joining (along with the confirmation of probation period)

Individual performance has been rated at maximum in Promed.

Received “Global Appreciate Award 2009” for the outstanding performance and exceptional commitment in Ranbaxy.

Received “Team Excellence Award 2007” for the outstanding performance and exceptional commitment in Ranbaxy.

Filed 3 ANDAs successfully for Ophthalmic products in USA.

MRPs of 50 products and DCPs of 60 products concluded successfully in Europe.

Submitted first NEES (Non XML eCTD Electronic Submission) as well as e-CTD in Europe in 2007 & 2009 respectively.

Joined Ranbaxy as Sr.Research Scientist in the year 2003 and in a period of one year four months, I have been promoted to the position of Group Leader, grade B1.

Again after subsequent two years, I have been promoted to the position of Group Leader, grade B2.

Again after subsequent two years, I have been promoted to the position of Group Leader, grade B3.

Individual performance has always been rated at 110% and 125% (maximum) in Ranbaxy.

Presented a paper in “Medicinal Chemistry Section” at the 43rd Indian Pharmaceutical Congress held at Goa,India

Attended Residential Training Programmes viz., Managing Performance & Development, Time Management & Presentation Skills, Stepping into Leadership” Programme & Building Innovation Champions.

Attended Global Regulatory Meet 2010 during 22-25 Feb 2010 at Ranbaxy, Gurgaon, India.

Attended Regulatory workshop during June 2011 at AZ, Manchester, UK

Attended ASIAPAC operations workshop during Oct 2011 at AZ, Japan

Got merit scholarships after 12th from Education board, Andhra Pradesh, India.

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