Dr. Hristina Nina Litovin Email & Phone Number

• 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.

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

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

• 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.

Kosovo

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).

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.

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.

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.

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.

Doctor Of Science, Pharmaceutical Sciences, Phd Pharmaceutical Sciences

Activities and Societies: Member of Macedonian Pharmaceutical Chamber Member of Management Board of Association of Cannabis manufacturers.

M.Sci., Pharmaceutical Technology, Nanotechnology, M.Sci. Pharmaceutical Sciences

Formulation and evaluation of solid lipid nanoparticles loaded with budesonide for delivery to the inflamed colonic mucosa

Specialization In Pharmaceutical Technology, Nanotechnology

Bachelor'S Degree, Pharmaceutical Technology, Graduated Pharmacist

Preparation and evaluation of lidocaine HCl loaded liposomes