Contact Cell : +91-984******* email: email@example.com
Address: Swargam Apartments, 8th Main Road, K.B. Nagar, ADYAR, CHENNAI.- 600020, INDIA
• Pharma professional with 18+ years of experience in pharmaceutical industry.
• Professionally trained individual with core experience in Global Regulatory Affairs ensuring high standards of quality in drug products, and working with culturally diversified technical teams.
• Enriched with diverse functional experience in Pharmaceutical Industry include regulatory affairs, project management, formulation development, and technical services.
• Professional expertise includes product registrations, handling regulatory audits, and customer support.
April 2007 to
Present Actavis Pharma
Head - Regulatory Affairs & Compliance
Major Job responsibilities :
Registration of Products in US, EU, Emerging Markets, Asia Pacific and ROW Countries.
I joined Actavis and developed Regulatory Affairs department from the scratch.
• As functional Head of Regulatory – I am responsible for setting up & managing regulatory function effectively for preparation, review & submission of ANDAs / MAAs to US and European Regulatory Agencies.
• Setting strategic direction, establishing a framework of standards and strategies in product development and technology transfer, ensuring compliance, documentation, as per systems.
• Co-ordination on technical matters with product development teams located abroad in Iceland, Malta, UK & USA.
• Accountable for developing procedures drive excellence training, growth & development of staff.
• Correspondence within and outside the organization to ensure compliance of regulatory matters.
• Provide in-puts to the mfg.site on regulatory requirements and guidelines.
• Provide guidance to regulatory associates in compilation of dossiers.
• Manage and allocate resources in RA group.
• Ensure regulatory submissions within time frames targeted by Management.
• Accountable for filing responses to deficiencies and follow up until product approvals.
• Responsible for review of ANDAs, Amendments & Supplements and Annual Reports.
• Accountable for keeping records of all filings, queries from FDA and all correspondence to FDA.
Actavis is implementing electronic submissions software for product filings.
I am responsible for recruitment of regulatory staff & training them in usage and implementation of electronic software.
Domestic Regulatory Affairs (Indian Licencing activities):
• Responsible for obtaining various types of regulatory approvals (licences / permissions etc) from Indian Drug Regulatory Authorities –(State FDA& DCGI).
• Obtaining Narcotics permissions from CBN, Gwalior, INDIA
Keeping a track and maintaining records of all regulatory submissions and approval dates, and ensure record keeping in compliance with company process.
• Monitor change control proposal to eliminate non-compliance risks etc.
• Participate in Regulatory Audits.
• Accountable for developing department SOPs and train the people.
• Sharing of knowledge with cross-functional teams through internal training programs.
• Harmonization of procedures & practices across all sites of Actavis with respect to Regulatory Function.
PROJECT MANAGEMENT :
Actavis is a multinational generic pharma company, having development labs and manufacturing units across the globe. Products are being developed at one site and transferred to another site for manufacturing and commercial supplies. My role is to drive the product transfers between the sites, and work as the interface with Global R&D centres, manufacturing sites, mktg. offices in US, Iceland, Malta, UK and Operations site at Chennai, India.
• Project Feasibility Study
• Handling product transfers (site transfer activities)
• Driving Project meetings with Cross Functional Teams
• Highlighting the Technical issues / difficulties in execution of each and every project
• Monitor, Control and Track project timelines and milestones
• Provide inputs and guidance to cross functional teams for execution of projects.
• Reporting the updates and progress on various projects to upper management from time to time.
• Co-ordination with Overseas technical teams within the Organisation (like R&D centres, Mfg. units, Mktg Offices, Corporate Office located in various cities in US and Europe)
Apr 2007 Sun Pharmaceutical Industries Ltd (SPARC)
Sr.Manager - Regulatory Affairs
Major Job Responsibilities:
• Product Registrations in regulated markets includes US, EUROPE, and ASIA Pacific markets.
• Driving RA team in dossier submissions in various Emerging and less regulated markets includes South Africa, and Latin American countries, Brazil, Russia and CIS, Mexico, Colombia, and Peru.
• Timely preparation and submission of high quality CMC documentation.
• Review of Technology Transfer Documents (TTDs).
• Review & Approval of Art Works (Label, Outer Carton, Pack Insert, etc)
• Actively involved in conducting Bio-equivalence (BE) studies in connection with registration of products in various countries.
• Correspond with regulatory bodies and act as company representative on all regulatory affairs matters
• Correspondence within and outside the organization to ensure compliance of regulatory matters
• Submission of responses for deficiencies received from regulatory authorities
• Guiding internal departments like R&D, CQA, QC, Manufacturing, packaging etc, on regulatory requirements.
Domestic Regulatory Affairs (Indian Licencing activities)
• Obtaining Manufacturing Licences and various other permissions from Gujarat Sate FDA and Drugs Controller General India (DCGI).
Nov 2004 Aurobindo Pharma (APL R&D Centre)
Sr.Scientist – Regulatory Affairs
When I joined Aurobindo Pharma, there was no structured Regulatory Affairs function. After I joined the company, I recruited the people, trained them and developed full-fledged Regulatory function to handle regulated markets like US, EU, and Emerging Markets.
Major Job Responsibilities:
• Establish regulatory set up and required services for submission of dossiers for US, and EU.
• Product registrations in US, EU and Emerging Markets.
• Driving regulatory submission for Brazil, South Africa, WHO, Asia Pacific, less regulated markets and ROW markets.
• Guide cross-functional teams on regulatory requirements and strategies.
• Actively co-ordinating BA/BE Studies in connection with product registrations.
• Review of technical data packages generated by APL R&D Centre, before it was transferred to manufacturing sites for execution of trial / exhibit batches.
• Facilitating and handling site inspections by regulatory authorities of various countries.
Licencing Activities (Domestic Regulatory):
• Submission of applications for obtaining various types of licences / permissions from Drugs Controller General India (DCGI) & Andhra Pradesh State Drug Regulatory Authorities (State DCA)).
• Obtaining various regulatory approvals from AP State DCA (Mfg.licence, COPP, Free Sale Certificate, GMP Certificate etc)
• Involved in conducting Clinical Studies in connection with product registration and supported Medical Affairs team in getting new product approvals.
• Instrumental in getting WHO GMP certification from Central Drugs Standard Control Organisation (CDSCO).
I worked as Interface between Aurobindo Pharma and Health Authorities of various countries.
I successfully handled inspections by regulatory agencies of various countries.
Sept 1997 to
Aug 2001 Dr. Reddy’s Laboratories
Assistant Manager – Regulatory Affairs
Major Job Responsibilities
• Compilation of registration dossiers for submission in various countries.
• Worked for various regions (Emerging Markets, Asian countries, African countries, Brazil, GCC countries, Latin America, Russia & CIS regions)
• Review and Approval of product Art Works & Labels.
• Preparation of standard operating procedures (SOPs) related to Regulatory Affairs Dept.
• Handling of queries from various regulatory Agencies, includes Indian regulatory authorities.
• Implementation of ERP systems (SAP) in regulatory affairs department
I worked as Interface between Manufacturing Plant, Marketing Dept, Corporate Medical Services (CMS) Dept, and Corporate Affairs Dept, etc, for conducting clinical trials in connection with product approvals. I handled regulatory submissions as per requirements.
Licencing Activities: my additional responsibilities includes:
• Meeting domestic statutory requirements (submission of applications for obtaining various types of licences / permissions from Drugs Controller General India (DCGI) & Andhra Pradesh State Drug Regulatory Authorities (State DCA)).
• Obtaining new product approvals from DCGI.
• Obtaining various regulatory approvals from AP State DCA (Mfg.licence, COPP, Free Sale Certificate, GMP Certificate etc)
• Obtaining Narcotics permissions from CBN, Gwalior.
• Involved in conducting Clinical Studies in connection with product registration and supported Medical Affairs team in getting new product approvals for many products of DRL.
• Instrumental in getting WHO GMP certification from Central Drugs Standard Control Organisation (CDSCO) for all sites of Dr. Reddy’s Labs.
May 1995 to
Aug 1997 Natco Pharma Limited
Hyderabad, Kothur Plant, INDIA
Senior Executive – R & D and Regulatory Affairs
I was part of R&D team and in-charge of Plant Regulatory Affairs
my major responsibilities:
• Formulation Development.
• Procurement of Speciality Chemicals for R&D projects.
• Analysis & Testing of products developed in R&D laboratory.
• Responsible for monitoring stability program and involved in Testing of Stability Samples.
• R&D documentation activities, includes preparation of Batch Manufacturing Records, Batch Packaging Records, Product Specifications, Testing Procedures, etc.
• Review and Approval of Art Works like Labels, Cartons, PIL etc. for all R&D products.
• Review of all promotional materials for its contents and regulatory compliance.
My additional job responsibilities
• Providing technical documents for submission of registration dossiers in various countries.
• Arranging samples for submission of registration dossiers in various countries.
• Analysis & Testing of products developed in the R&D laboratory.
• Responsible for monitoring stability program for all formulations and dosage forms manufactured by Natco and also involved in Testing of Stability Samples.
Apr 1995 Natco Pharma Limited
Hyderabad, Corporate Office, INDIA
Executive – Technical Services
I started my career with Natco Pharma in Hyderabad. This position was my first assignment in Natco. My main responsibilities:
• Correspondence with various types of vendors in India and their foreign principals abroad, in connection with procurement of machinery, equipment and specialty chemicals for Natco group.
• Coordination of Natco plant visit by foreign customers and State regulatory and Govt. authorities.
• Coordination with Loan Licence parties and internal customers (technical teams) on various technical & commercial matters.
• Played vital role as single point contact for Natco Pharma’s loan licensing parties.
• Co-ordination with Mfg. sites, for technical documents required for product registrations.
• Supported Exports Marketing dept, and Drug Registration dept in submission of registration dossiers in various countries.
• Monitoring licence renewal timelines and in-time submission of renewal applications.
• Interface between external partners / vendor companies, and Natco manufacturing units.
• During my tenure with Natco, I established, built and maintained transparent, honest and trusting relationships with external partners / loan licensing parties of Natco Pharma.
• Established Regulatory Affairs Dept. from scratch in Aurobindo Pharma and Actavis Pharma.
• Established Regulatory Systems for submissions of dossiers in CTD & eCTD format.
• Recruited and trained more than 90 people in regulatory function.
• Heading International Regulatory Affairs function.
• Good experience in product registrations in various Regulated and Emerging Markets, like US, Europe, Canada, South Africa, Brazil, Russia and CIS, South East Asia, Asia Pacific, Australia, African and Latin American Regions.
• Expert in Strategic submissions and Life cycle management of product approvals.
• Received regulatory approvals for more than 600 dossiers from regulatory Agencies of various countries (Regulated and Non regulated markets).
• Contributed my previous organisations in strategic development of full-fledged regulatory function, and to the success of product launches and commercial supplies.
• Extended support to Clinical studies of many products, in connection with product registrations.
• Successfully handled audits by various Regulatory Agencies include USFDA, MHRA, WHO, ANVISA, South Africa, Colombia, Kenya, Uganda, Nigeria, etc.
• Good relationship with the Indian regulatory authorities. I obtained more than 250 product approvals from the State and Central Drug Regulatory Authorities in India.
• Contributed to my previous organizations in developing and/improvement of regulatory functional processes and procedures.
• Supported marketing function in gaining optimum markets access in various countries, by successfully getting regulatory approvals in time, maintaining the product licences and renewals, and ensuring the regulatory compliance.
• Supported regulatory audits of manufacturing facilities for cGMP compliance.
• Participated in new product review meetings with top managements, and finalized product pipelines and regulatory filing schedules for various markets.
1999 M.B.A .
Hyderabad, Andhra Pradesh, India
Dr.Harisingh Gour University
Sagar, Madhya Pradesh, India
1989 B.PHARMA ¬
Warangal, Andhra Pradesh, India
Personal Skills and Capabilities
I have the following skill sets to excel in my professional life:
• Excellent communication skills (written and verbal).
• Strong leadership skills and influencing people in the team.
• Strong interpersonal, organizational, presentation, and negotiation skills.
• Driving cross-functional teams
• Highly committed and team oriented
• Flexible and adaptable to the new environments and systems.
• Expertise in regulatory strategy dev. and master dossier processing for global submissions.
• Maintain leadership level communication and keep management informed on deviations and provide corrective actions.
• Ability to develop and communicate strategic vision to the team.
• Strong understanding of Research and Development, Generics, Regulatory Affairs, Compliance, Audit functions and Quality Assurance.
• In depth understanding of the pharmaceutical business models.
• Ability to recruit, coach and develop people and teams to support the talent pipeline.
• Result oriented and delivers the goods in time as per the requirements.
• Aware of Indian and International cultures and treat the people accordingly.
• Manage diverse multicultural and multi-disciplinary teams.
• Respect the people at all levels according to their traditions and cultures.•
• Familiar with electronic data management software and eCTD software.
• eCentral software used for electronic CTD filings – provided by MedXview.
• Docubridge – electronic CTD filing software provided by Lorenz
• Qumas – Quality documents management software.
• Good knowledge of ERP software (SAP and JDE) - manufacturing function.
• MS Outlook - Mail communications and Organising Meeting.
• MS Projects - Planning and tracking on the progress of various Projects.
• Trackwise – software used for Change Controls & Deviations, etc.
• MS Office - MS-project, Power Point, document management systems, etc.
• Lotus Notes - Mail communications and various Database Development.