Dr. Hristina Nina Litovin

Dr. Hristina Nina Litovin Email and Phone Number

COO at SINCERITAS @ Sinceritas EU
skopje, karpoš, macedonia
Dr. Hristina Nina Litovin's Location
Skopje, Skopje Statistical Region, North Macedonia, Macedonia, the Former Yugoslav Republic of
Dr. Hristina Nina Litovin's Contact Details

Dr. Hristina Nina Litovin work email

Dr. Hristina Nina Litovin personal email

n/a
About Dr. Hristina Nina Litovin

As a Chief Operating Officer (COO) I'm among leading scientific advisors to build a pharmaceutical company on a green field, and oversee various aspects of regulatory compliance, establishment and maintenance of robust pharmaceutical quality management system, operational excellence, strategic planning, leadership and team development, innovation and technology adoption, financial acumen and ethical ans social responsibility. By providing technical expertise with strategic vision and effective leadership, keeping abreast of industry trends, regulatory changes, and technological advancement, ensure competitive and successful pharmaceutical operations of the company. I have over 20 years managerial experience in pharmaceutical industry within Research and Development, Regulatory Affairs and Business Development. Since 2006 my research is focused on lipid nanoparticles as innovative pharmaceutical dosage systems for targeted delivery of active ingredient to specific organ/tissue. I have know-how in development of drug delivery systems for BCS II, IV active ingredients by improving poor dissolution and bioavailability. I also have experience in pharmaceutical product development covering solid dosage forms, semi-solids, liquids and small volume parenterals within different business segments: generic products, food supplements and cosmetic products in a highly regulated GMP environment. Having possibility to work in various international roles within pharmaceutical industry, I gained extensive experience in material science, new process development, technology transfer, stability studies and quality control, bioequivalence studies, quality management, regulatory requirements and commercialization of products derived from research. I am a highly motivated, self-starting person with ability for strategic thinking. I have strong organizational and team leading skills.

Dr. Hristina Nina Litovin's Current Company Details
Sinceritas EU

Sinceritas Eu

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COO at SINCERITAS
skopje, karpoš, macedonia
Website:
sinceritas.eu
Employees:
14
Dr. Hristina Nina Litovin Work Experience Details
  • Sinceritas Eu
    Coo
    Sinceritas Eu Mar 2023 - Present
    • Quality management – Expertise in establishment and maintenance of robust Pharmaceutical Quality management system, GACP and ISO standards. • Regulatory compliance – In-depth knowledge of pharmaceutical regulations, and other relevant industry standards including GMP, GACP, ISO. Ability to interpret and navigate complex regulatory landscapes ensuring that operations comply with local and international regulations.• Operational excellence – Optimization of manufacturing processes to achieve operational efficiency, cost-effectiveness and high-quality production. Continuous improvement methodologies in pharmaceutical operations. • Strategic planning – Development and execution of strategic planning that align with the organization’s overall goals and objectives. Translation of strategic vision into accountable plans for production, process development and quality control. • Cross-functional collaboration – Strong interpersonal and communication skills to collaborate effectively with board members, executives, department heads and teams across different functions. Foster a collaborative culture that promotes information sharing and problem-solving.• Risk management – Expertise in identifying, assessing and mitigating risk associated with pharmaceutical manufacturing and supply chain operations. Implementation of risk management strategies to ensure business continuity.• Innovation and Technology adoption - Awareness of emerging technologies in pharmaceutical manufacturing and willingness to adopt innovative solutions. Ability to integrate technology to improve production processes and enhance product development capabilities.• Financial acumen - Strong financial management skills, including budgeting, cost analysis, and resource allocation. Ability to balance financial considerations with the need for quality and compliance.
  • Sinceritas Eu
    Chief Science Officer
    Sinceritas Eu Jul 2020 - Mar 2023
    Skopje, Skopski, North Macedonia
    Provide expert oversight to scientific matters. Render efficient support to product development. Developing scientific vision for the company. Lead cross-functional teams responsible for quality assurance, quality control, manufacturing, supply-chain and GxP compliance.• Leading auditee team for successful outcome of inspection for manufacturing licence - pharmacetucal operations• Leading auditee team for successful outcome of national and EUGMP compliance inspections
  • Sinceritas Eu
    Co-Chief Scientific Officer
    Sinceritas Eu Oct 2019 - Jul 2020
    Align research and scientific priorities with the overall mission and goals of the Sinceritas leading scientific projects in collaboration with Universities and company presentation to potential clients• Leading team for cultivation licence and other applicable licences for staring cultivation operations
  • Sinceritas Eu
    Head Of Qa And R&D
    Sinceritas Eu Mar 2019 - Oct 2019
    • Establishment of PQS within company;• Development of URS, validation/qualification of clean rooms;• Development of SMF, SOPs, DMS, VMP, RSM, CC, specifications, COA, MOA, MBP, MBR;• Development of supplier assessment;• Selection of QC and production equipment;• Development of technological processes and new products development;• Establishment of QC laboratory and production;• Scientific advisor in clean room project;• Establishment of GACP standards.
  • Pharmas D.O.O.
    Managing Director
    Pharmas D.O.O. Dec 2012 - Mar 2019
    Kosovo
  • Pharmas D.O.O.
    Manager For Regulatory And General Affairs
    Pharmas D.O.O. Mar 2012 - Mar 2019
    Macedonia
    • Management of Regulatory affairs CHC program for International markets;• Regional Regulatory Affairs manager for SEE (South East Europe);• Market access in MAK region (Macedonia, Albania and Kosovo) - timely preparation of high-quality dossiers, review, submission, follow-up of new MA applications to the local authorities, timely submission of variations, renewal applications, PSURs;• Qualified Person for Pharmacovigilance, creation and implementation of Risk Management Plan for generics according to EU regulation (global PhV office), case processing in the global database, data entry, MedDRA coding, narrative writing, review and assessment of ICSR, SAE/AE reports;• Part of the global team for New Product Development (food supplements) selection and organization of a local RA specialists, training and mentoring;• Representation of the company in front of the authorities, organs of the Ministry of Health, Health insurance fund etc., negotiations with Regulatory Authority Bodies and Health Insurance Fund for creation of the, price politics of the generic drugs;• Effective and adequate launch project management and communication;• Establishing the company in the Macedonian market (personal selection, office selection and organization of other necessary equipment for representative office and employees in the startup company).
  • Jaka 80 Ad
    R&D And Ra Manager
    Jaka 80 Ad Jan 2006 - Feb 2012
    Macedonia
    • Pharmaceutical product development (solid, semi-solid and liquid dosage forms and small volumeparenteral);• Food supplements and cosmetic product development;• Pre-formulation, material science, formulation of final dosage forms, stability studies and technology transfer;• Process validation, process optimization, analysis, and evaluation;• Adherence to quality and regulatory requirements;• Review and approve CTD dossiers modules 1, 2, 3; SOP's; development reports; technical dossiers;PSUR's; RMP; bio-equivalence trial batches;• Contract manufacturing operations.
  • Jaka 80 Ad
    Researcher In R&D Department
    Jaka 80 Ad Oct 2001 - Dec 2005
    Skopje
    • Pre-formulation and formulation studies for generic pharmaceutical products and OTClaboratory trials, scale-up, compatibility studies, stability studies, pre-selection of containerclosure system;• Writing module 3, sections: 32p1, 32p2, 32p3, 32p4, 32p7, 32p8 from CTD dossier, SOP's.
  • Institute For Public Health
    Qc Analyst
    Institute For Public Health Jan 2001 - Sep 2001
    Skopje
    • Quality control of drug products, active ingredients, and raw materials;• Working experience on HPLC and GC chromatography, UV/VIS spectrophotometer;review of NTA dossiers, Method of analysis;• Writing analysis report.
  • Ss. Cyril And Methodius University, Skopje, Macedonia
    Assistant/Demonstrator
    Ss. Cyril And Methodius University, Skopje, Macedonia Mar 1999 - Dec 2000
    Faculty Of Pharmacy
    • Practical education and examination of students;• Participation in science projects on development of innovative drug delivery systems, particle size analysis, freeze-drying (lyophilization) and spray-drying.

Dr. Hristina Nina Litovin Skills

Regulatory Affairs Pharmaceutical Industry Regulatory Submissions Pharmaceutics Gmp Regulatory Requirements Validation Clinical Trials Fda Sop Technology Transfer Pharmacovigilance Glp Clinical Development Change Control Capa R&d Iso 13485 Hplc Risk Management Plans Nanotechnology Experimental Design Stability Studies Standard Operating Procedure Scientific Reports Scientific Papers Scientific Data Management Scientific Writing Scientific Presentation Scientific Management Scientific Review

Frequently Asked Questions about Dr. Hristina Nina Litovin

What company does Dr. Hristina Nina Litovin work for?

Dr. Hristina Nina Litovin works for Sinceritas Eu

What is Dr. Hristina Nina Litovin's role at the current company?

Dr. Hristina Nina Litovin's current role is COO at SINCERITAS.

What is Dr. Hristina Nina Litovin's email address?

Dr. Hristina Nina Litovin's email address is li****@****home.mk

What schools did Dr. Hristina Nina Litovin attend?

Dr. Hristina Nina Litovin attended Faculty Of Pharmacy - Skopje, Ss.cyril And Methodius University Of Skopje, Faculty Of Pharmacy - Skopje, Ss.cyril And Methodius University Of Skopje, Faculty Of Pharmacy - Skopje, Ss.cyril And Methodius University Of Skopje, Faculty Of Pharmacy - Skopje, Ss.cyril And Methodius University Of Skopje.

What skills is Dr. Hristina Nina Litovin known for?

Dr. Hristina Nina Litovin has skills like Regulatory Affairs, Pharmaceutical Industry, Regulatory Submissions, Pharmaceutics, Gmp, Regulatory Requirements, Validation, Clinical Trials, Fda, Sop, Technology Transfer, Pharmacovigilance.

Who are Dr. Hristina Nina Litovin's colleagues?

Dr. Hristina Nina Litovin's colleagues are Gjorge Gogov, Marina Galeva, Vlatko Trajkovski, Ana Sjekloća, Riste Janevski, Stojna Jordanova Stojimenova, Zlatko Georgievski.

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