Visshnupriya

Lead the Regulatory Affairs Department, managing both the RA team and designer team. Oversee all new MAL registrations, including product classification, formulation advisory, and regulatory strategy in alignment with customer requirements and NPRA guidelines. Manage the maintenance and renewal of ready MAL registered products, ensuring ongoing compliance with NPRA and other regulatory bodies. Provide expert formulation advice and regulatory guidance to customers, balancing compliance with market expectations. Review and approve labeling, artwork, and promotional materials to ensure adherence to NPRA and FSQD standards. Coordinate with R&D, Marketing, and Quality Assurance to ensure smooth product launches and compliance from concept to market. Represent the company in audits, inspections, and meetings with health authorities, addressing compliance matters proactively. Optimize departmental workflows, mentor subordinates, and set measurable KPIs to enhance performance and efficiency. Developed strong working relationships with staff, fostering a positive work environment. Supervised day-to-day operations to meet performance, quality and service expectations.

• Liaised with local Health Authorities (NPRA, MDA,HSA) for regulatory activities, licenses, and permits across three APAC markets. Developed and recommended regulatory submission strategies with defined timelines during new product planning stages. Reviewed technical dossiers for new products and prepared supplementary documentation when required. Managed timely approvals and renewals of product and company licenses, variations, and permits in accordance with regulations. Ensured compliance in advertising, promotional materials, and labeling before market release. Established and maintained strong relationships with regulatory officials to facilitate product approvals. Monitored regulatory changes in Malaysia, Singapore, and Brunei, advising stakeholders on potential business impacts. Provided pharmacovigilance oversight, maintaining systems and ensuring CAPA implementation post-market.
• Key Responsibilities: (RA & Pharmacovigilance Specialist Malaysia & Singapore & Brunei)

• Responsible for total products (Health Supplements, Traditional, Cosmetic, and Foods) regulatory affairs.
• Responsible for new product registration for Pharmaceutical products in NPRA.
• Responsible for new product registration, renewal, and correspondence follow-up for Cosmetic products in Malaysia.
• Responsible for variation application for health supplements and traditional products in the National Pharmaceutical Regulatory Agency (NPRA).
• Responsible for the application of Labeling Advisory Services and Food Labeling Screening to Bahagian Keselamatan dan Kualiti Makanan (BKKM).
• Liaise with local regulatory authorities as well as our customers pertaining to regulatory affairs, including product registrations, variations to existing products, and renewals.
• Provide guidance and direction to relevant parties on local regulatory requirements for product label change, manufacturing change, shelf life, and changes to technical specifications of devices according to NPRA.
• Ensure good housekeeping and up-to-date regulatory documents are maintained in hardcopy and softcopy.
• Responsible for variation and renewal of imported products and contract products in Malaysia.
• Responsible for applying Good Manufacturing Practice (GMP) certificate, Certificate of Pharmaceutical Product (CPP), and Indication Certificate.
• Responsible for the renewal and update of Manufacturing license and Imported license.
• Responsible for checking packaging artworks for printing purposes prepared by the Graphic designer.
• Liaise with auditors if needed (HACCP, GMP, ISO22000, HALAL).
• Responsible for reviewing promotional materials to ensure contents follow NPRA & KKM.
• Serve as document controller for RA team, handling the entire spectrum of regulatory affairs work procedures pertaining to National Pharmaceutical Regulatory Agency, JAIS, JAKIM, foreign embassies, and any other governmental bodies within the timeline and timeframe set by NPRA.
• Responsible for collecting necessary documents from customers for token application, liaising with the account department for payment purposes, and following up on renewal intervals when overdue to avoid access interruption issues.
• Responsible for the application for change of product holder for customers and liaising for payment and needed documents to prove the changes are genuine and true by law.
• Liaise with the local Health District Officers of the Ministry of Health for Health Certificate application and endorsement within the timeframe needed.
• Coordinate with R&D and Sales & Marketing departments for sample submission purposes.
• Liaise with R&D to prepare Nutritional fact test for BKKM Submission.
• Submission of Product Classification information and related documentation to determine product categorization before any registration ensues.
• Receive, record, and process any non-conformance product recall issues that arise from the public or authorities and recall the product according to several steps of procedures strictly required. Worldwide Environment - Waste Management Company to dispose of the products accordingly to the law to get the final confirmation 'Certificate of Waste Treatment and or Disposal' and send back to NPRA for approval status.
• Responsible for providing pharmacovigilance (post-marketing surveillance) support after product marketed into the market to avoid issues that can bring damage to the company's reputation and safety of consumers.
• Responsible for regulatory support to Sales & Marketing departments.
• Responsible for monitoring, creating, and overseeing RA team's workflow, the team performance required to complete a job as well communicate objectives.
• Responsible for presenting monthly meeting reports of RA department once compiled report from subordinates (RA officer and Graphic Designer).
• Reporting to General manager on any regulatory-related affairs.
• Assisting General manager and Factory manager on all the instructed matters and implementation.

• Liaise with individuals, families, and businesses to help clients understand their financial circumstances and how to reach their short-term and long-term financial objectives.
• Provide relevant financial information during an initial interview, answering questions about their total annual income, debt obligations, monthly expenses not related to debt, current investment holdings, savings account balances, tax liabilities, and insurance plans.
• Analyze this information and present realistic, meaningful recommendations based on their clients' financial situations and goals.
• Discuss many personal finance topics with their clients, including debt management, savings objectives and strategies, and personal and family budgeting.

• Responsible of new product registration for Pharmaceutical products (Poison schedule, Non poison schedule, New Biologic, Health supplement and Traditional) in National Pharmaceutical Regulatory Agency (NPRA).
• Responsible to compile and submission of dossier for new products according to CSTD format (Class I, II, III Devices) and main in-charged of new product registration, renewal and correspondence follow-up for Cosmetic products in Malaysia.
• Responsible of variation application for pharmaceutical products in National Pharmaceutical Regulatory Agency (NPRA).
• Liaise with local regulatory authority as well as overseas partners pertaining to regulatory affairs, including product registrations, variations to existing products and renewals.
• Provide guidance and direction to relevant parties on local regulatory requirements for product label change, manufacturing change, shelf life and changes to technical specification of devices according to Medical Device Regulations 2012 and Medical Device Act 737.
• Prepare amendment and notification submissions in compliance with application regulations.
• Liaise with Conformity Assessment Body (CAB) in Malaysia for matters pertaining to product verification and full product conformity assessment for Medical Devices.
• Preparation of documents and support CAB in EU Medical devices and full product conformity assessment for Medical Devices.
• Support internal audits at Representative authority sites.
• Ensure good housekeeping and up-to-date regulatory documents are maintained in hardcopy and softcopy.
• Responsible of application and maintenance of establishment licenses of Medical Devices.
• Responsible of variation and renewal of imported products and contract products in Malaysia.
• Responsible of applying Good Manufacturing Practice (GMP) certificate and Certificate of Pharmaceutical Product (CPP).
• Responsible of renewal and update of poison license, manufacturing license and imported license.
• Responsible check packaging artworks prepared by regulatory clerk and in charged maintain registration files for all registered Pharmaceutical products and Medical Devices in Malaysia.

• Responsible industrial internship training in the following divisions

• HOSPITAL KAMPAR PERAK HOSPITAL SULTANAH BAHIYAH KEDAH, SEREMBAN
• HOSPITAL TUANKU J'AAFAR SEREMBAN HOSPITAL ANGKATAN
• TENTERA KEM TERENDAK MELACCA HOSPITAL TANGKAK JOHOR
• HOSPITAL KAMPAR PERAK
• HOSPITAL SULTANAH BAHIYAH KEDAH