Dr.Vaibhav Kulkarni

Develop and implement a comprehensive strategy to support the company’s position, international reputation and image as a credible player in the Baby & Adult Nutrition category in Asia Pacific, leading the agenda on future development of the regulatory environment. Establishing and maintaining external partnerships and programs with organizations such as NGOs, Government at all levels, Regulators, Policy Makers, KOLs, HCPs and trade associations, shaping the future destiny of the category. Maintaining a world-class culture of ethics, compliance and safety for people and products using highest standards of scientific practice and ethical behaviour.Support Marketing/Nutrition/R&D/Medical to ensure nutritional accuracy and regulatory compliance across all elements of the communication and regulatory submission processes. Build and maintain professional relationships with regulatory authorities (regional and national), NGOs and Key Opinion leaders in order to maintain/build credibility of the company and shaping a favourable regulatory environment. Implement awareness programs on the Regulatory requirements and Marketing Guidelines on Infant formula, Follow-On and Growing Up Milk.

Provide regulatory support, guidance and advice with respect to regional and local SRA functions in order to enable the organization to be compliant with regulatory legislation. Obtain and maintain leadership in trade associations either personally or through local regulatory functions to shape the regulatory environment in the country/region. Monitor the Regulatory Environment and stay abreast of upcoming changes that may affect the company, as well as proposed changes with respect to the WHO Code compliance/implementation Uphold linkage and compliance to the corporation’s principles, including safety, regulatory, nutrition, health policy and corporate social responsibility. Support Crisis Management process as required. Review and approve formulation, label and promotion material according to FSSA, Magic Remedies Act, ASCI, PFA & IMS Act, Standards for Weights & Measures Act & regulations thereunder. Keep and enhance the relationship with relevant Indian Health Authorities and KOLs, particularly DCGI, FDA, PFA, FSSA, FICCI, HADSA, PFNDAI, AYUSH and BIS. Participate as influential member in various committees that makes/ modifies laws pertaining to Food and Nutrition.Member of R&D Advisory Board for Pacific Asia & Africa(PAA) region.

DRA • Import Registration for New products. • Alignment of Global DRA with DRA-India Cluster. • Product Registration(locally manufactured/Imported) in Ex-India market.(Srilanka, Nepal, Bangladesh) • Providing regulatory support for local registration on regulatory related issues. Drug Safety & Pharmaco-vigilance(DSP) • Aligning India Cluster Drug Safety & Pharmaco-vigilance with Global DSP. Innovation • Joint responsibility with R&D for preparation of BFI & PDP. • Aligning India Cluster with Global Innovation team on various Innovation processes. • Chairing Innovation meetings.

• Manages company wide regulatory submissions for import permissions in Form 10 for JJPP. • Interacts with regulatory agencies for INDOMED • Understands and influences current requirements of regulatory agencies like DCGI & Local FDAs. • Manage or participate in Recalls, Stop-Shipments and other potential regulatory actions for originated/requested by source companies. • Provides regulatory documents to the countries in Asia Pacific. • Provides regulatory approval for internet publications. • Provides regulatory approval for copy material and promotional activities. • Provides regulatory approval for web-casting. • Heading the Compliance Management team for the originating companies & interphasing between local marketing and the complaint management department of source company. • Responsible for co-ordinating clinical trials and market studies of JJMI products and handling of complaints of imported products of JJMI. • Member of Global Counterfeit Management Team & responsible for issues pertaining to counterfeits in Asia Pac countries. • Member of Regional Regulatory Council for ASIAPAC (Johnson & Johnson Medical).

To create systems and processes for efficient functioning of regulatory department and also to support export department by providing technical expertise on product registration. Providing technical support to export department in product registration process by overlooking the overall preparation of product dossiers (country specific), which can increase the export revenue of the company on long term. Overall In-Charge of Product Technical Complaint Division (PTC) & to establish the systems and procedures to handle Product Technical Complaints (PTCs) in accordance with regulatory requirements and Quality Standards and to determine if any corrective action needs to be implemented. Providing technical assistance to the International Division for possible export tie-ups with other generic companies. Providing & helping subordinates with overall technical expertise to complete their task(Dossier preparation) in time. Co-ordinating with the prospective buyers abroad for their technical requirements to be submitted to the MOH. Co-ordinating & Technically overlooking factory regulatory affairs for their adherence to the quality systems & also getting their assistance in the process of loan licence/third party manufacturing of export driven products. Technical feedbacks to export department for product registration (Country wise). Overlooking the overall product registration process of the Product Registration Cell Department. Providing trouble shooting solution to the technical issues of the buyer (country wise) Providing technical expertise to the factory(R&D, QC & Regulatory Affairs) for Product development. Prioritizing product registration process with the department after much consultation with export department, factory(R&D, QC/QA & Regulatory Affairs) and the country specific international buyers. Responsible for development of Quality systems for the regulatory departments(Factory as well as HO).

Export Registration – Customization of drug regulatory filings and it’s processing for each export market for the timely approvals. Regulatory Compliance – To ensure compliance to various regulatory procedures in connection to maintenance and re-registration of products in export market. Clinical Research – Application & follow-up actions on DCGI & DGFT/JDGFT submissions for clinical studies. Liaison with Purchase department for clearing clinical drug supply from customs. To create customized regulatory dossiers for export markets to support various applications to regulatory authorities for product registrations/amendments in the existing registrations and to track progress with different departments within Aventis India, Drug Regulatory Affairs – Paris to support business objective of registration of new products. To approve labeling text for the Packing material of different formulations marketed by Aventis India in various countries. To do the advance planning in consultation with DRA – Paris for future requirements in terms of international dossier/certificate/other related documents in order to ensure the timely & adequate support to meet the previously set dead lines for various projects related to export markets. To update the launch plans on regular basis to be in the line with export market. To provide all necessary regulatory support & co-ordination for registration / re-registration of products along with renewal of import licenses in Nepal, Srilanka, Russia, Ukraine, CIS, Thailand, Philippines, Malaysia, Singapore & Venezuela to strengthen the export business of organization. To support the regulatory liaison person of each country to ensure the progress of on-going registrations to maintain the continuity of registration in order to avoid any adverse impact on export business of the organization. To provide the necessary help in terms of dossiers to other countries in Asia Pacific region on special request from DRA, Paris.

To design new assay procedures to evaluate the efficacy of a drug , which includes assisting in monitoring progress and assessing response to therapy in different drugs. Designed new assay procedures for analysing antioxidants like Superoxide dismutase , Catalase, Glutathione peroxidase and Thiols. Also, designed procedure for assessing Lipid Peroxidation. Was in-charge of the project on setting up of method for assessing carbon monoxide levels in blood. II) Location of centres for conducting clinical research studies. Designing the protocol and proformas for the same. In all, assisted in 14 clinical research studies which includes multicentric trials as per GCP ICH guidelines. The multicentric trials were carried out at 8 centres on all important molecule, Sildenafil Citrate , Nimesulide OD 400, Nimesulide OD 200 etc.. Also, trials on various natural antioxidants in various disease conditions like various types of cancer, age related macular degeneration, diabetes and asthma were carried out . These antioxidants are all derived from natural sources. Also, involved in the cell- line studies for breast cancer and prostrate cancer. A collaborative venture with Cancer Research Institute, Mumbai. III) In- charge of conduction of bioavailability & bioequivalence studies. Screening of volunteers, designing of protocol and proformas . Totally, 76 bioavailability studies( inclusive of In-house as well as at bioavailability centres) for various NDDS and Herbal formulations carried out. These formulation includes Nimesulide OD, Ciproflaxacin OD , Cefadroxil OD, Acyclovir OD, Celecoxib OD, Rofecoxib OD, Ondansetran OD,Ofloxacin OD, Ambroxil OD and Amoxycillin OD. IV) Requisite knowledge of patent search . Assisted in providing various data for US patent. Acquired requisite knowledge of computer & internet surfing. Well versed with GCP ICH guidelines, US FDA guidelines, UK MCA guidelines, South African MCC guidelines.