RAYNA KOSTOVA
Regulatory affairs and Pharmacovigilance manager
Sofia
Summary
Accomplished Senior Consultant involved in Regulatory affairs submissions and Pharmacovigilance services. Proven strong analytical and project management skills. Successful history of adapting to new challenges and finding effective solutions for various Regulatory challenges and issues.
Organised and reliable RA and PV manager with 18 years of experience. Successful at managing multiple priorities with positive attitude.
Overview
20
20
years of professional experience
Work History
Regulatory affairs and Pharmacovigilance consultant
RayaPharm Ltd.
Sofia, Sofia-Capital
09.2019 - 02.2026
- Company manager, Consultant Regulatory affairs and PV services. Pharmaceuticals, Medical device, Foods, Biocides, Cosmetics.
- Post licensing regulatory submissions, Lifecycle management, new MAA submission and follow-up
- Interaction with health authorities on behalf of client’s company
- Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling, PI translation from English/Bulgarian and Bulgarian/English
- LQPPV function for PV projects for different companies
- Gain regulatory approval
- Provide regulatory advice and strategy
- Regulatory intelligence reports
- Liaised closely with clients throughout consulting process, ensuring satisfaction at every stage.
- Recommended improvements on business processes for optimised performance and profitability.
- Managed multiple projects simultaneously whilst ensuring timely completion and quality control.
- Reviewed company policies regularly, aligning them with changing legal requirements.
- Ensured compliance with regulatory standards by conducting thorough audits and reviews.
- Enhanced client understanding of market trends, leading to informed decision making.
- Identified deviations from standard operating procedures, understanding causes and preventing reoccurrence .
- Located deviations from standard operating procedures, understanding causes and preventing reoccurrence.
Regulatory Affairs manager
Kohne Pharma GmbH
Sofia, Sofia-Capital
06.2017 - 10.2019
- Post licensing regulatory submissions, Interaction with health authorities on behalf of client’s company
- Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling: Regular linguistic reviews (complete PI of average 3 CP per month)
- Supervise the compilation of regulatory dossiers
- Gain regulatory approval
- Provide regulatory advice for project teams
- Liaise with external regulatory authorities
- Outsourcing and consulting services
- Ensured up-to-date knowledge of regulatory developments, quickly communicating necessary process changes to maintain compliance.
- Reviewed marketing materials for compliance with advertising regulations protecting the company against legal implications.
- Led negotiations with authorities, achieving favourable outcomes for the company.
- Achieved regulatory compliance by meticulously reviewing product labels and packaging.
- Communicated and negotiated effectively with cross-functional internal and external stakeholders for optimised project outcomes.
- Coordinated with departments for seamless execution of regulatory strategies.
Regulatory affairs and Pharmacovigilance manager
Freelance consultant
Sofia, Sofia-Capital
09.2015 - 06.2017
- RA Life cycle management procedures for all kinds of MP and MD: Labelling review and artwork compliance
- RA intelligence and legal compliance support: Medical device complete local legislation review
- Regular literature screening for Adverse drug events and creating reports for the customer on a weekly basis
- Supporting locally based pharma companies as well as companies without local established affiliates
- Strengthened stakeholder relationships through effective communication and engagement methods.
- Managed multiple projects simultaneously whilst ensuring timely completion and quality control.
- Cultivated strong relationships with clients to secure repeat business.
- Supervised project timelines for timely completion.
Regulatory affairs manager
B.Braun Medical Ltd.
Sofia, Sofia-Capital
08.2007 - 11.2014
- Qualified person for pharmacovigilance for Bulgaria: Local QPPV
- Complaint management officer (safety and quality) of drugs, medical devices, biocides
- Pricing and reimbursement registration expert for drugs and medical devices
- Warehouse license responsible pharmacist
- All local drug registration activities – life cycle maintenance: submissions for national, DCP and MRP, incl. renewals, all types variations, Product information translation, SmPC, PL, Labelling and artwork review and approval according QRD, artwork revision for compliance
- Notification of the complete MD portfolio to BDA, registration of all MD products in electronic register of BDA in 2013
- Registration of biocidal products to MoH
- Regular communication with local CA on daily basis
- Everyday communication with MAH (Headquarters Germany)
- ADR evaluation, data processing and submission, regular PSUR submission, RMP and DHCP letters upon request
- Conducting the procedure of product recalls, quality complaints, FSN, whenever a non-compliant product has been detected
- Responsible for internal and external PV and Quality Audit, CAPA planning and implementation, creation/ revision all relevant company SOP
- Regular training of the company staff on PV, MV and complaint management measures
- Price and PDL registration submission for all MP, regular external and internal price referencing and price policy strategies proposals. Pharmaco-economic analysis review as required for specific products
- Strategic planning and proposal of new product registrations; annual, quarterly/monthly RA budget forecast
- Regular archiving and maintenance of complete regulatory paper documentation and IT databases
- Responsible manager for warehouse legal compliance and storage conditions examined by CA inspections
- Distribution of drugs, medical devices, biocides, nutrition for special medical purposes, cosmetics mainly for professional use in hospital environment.
- Coordinated with departments for seamless execution of regulatory strategies.
- Devised comprehensive strategies that resulted in expedited approval from health authorities.
- Trained new employees effectively reducing their learning curve and increasing productivity sooner than usual.
- Assisted in policy formulation, leading to a more robust regulatory framework within the organisation.
- Liaised with health authorities for successful product registrations.
- Communicated and negotiated effectively with cross-functional internal and external stakeholders for optimised project outcomes.
- Reviewed marketing materials for compliance with advertising regulations protecting the company against legal implications.
- Optimised product development timelines by integrating regulatory considerations early on.
- Maintained up to date knowledge on regulatory changes to ensure consistent compliance in country of sale.
- Proactively identified potential risks, thus reducing instances of non-compliance.
- Led negotiations with authorities, achieving favourable outcomes for the company.
- Ensured adherence to industry standards, resulting in minimal non-compliance issues.
- Provided advisory support during audits; resulted in fewer discrepancies noted by auditors.
Sales expert and representative
KRKA Trade representation office
Sofia, Sofia-Capital
01.2007 - 06.2007
- Promote the company products to KOL at diagnostic consultation centres and to pharmacists at private and chain pharmacies, lead product presentations at organised medical promotional events
- Wholesale Drug distribution.
- Conducted market research, identified new trends in the industry.
- Kept meticulous records of customer interactions and transactions, tracked feedback for management review.
- Handled customer complaints promptly, ensured high levels of satisfaction.
- Developed strong relationships with stakeholders to facilitate sales growth.
- Presented products persuasively to potential buyers at trade shows and exhibitions.
- Engaged in regular networking events to establish valuable industry contacts.
- Kept up to date with competitors activities and market trends to inform sales efforts.
- Identified weak areas in sales processes and made suggestions for improvements.
- Provided customers with price information and handled financial transactions.
- Implemented training programmes to enhance team capabilities.
- Perfected sales presentations leading to higher conversion rates.
- Set up appointments with potential and current customers to discuss new products and services.
Medical representative
Ranbaxy Laboratories Limited
Sofia, Sofia-Capital
06.2006 - 12.2006
- Present medical information about the company products to KOL at diagnostic consultation centres and major hospitals and at private and chain pharmacies, lead product presentations at organised medical promotional events
- Drug distribution.
- Identified and secured new sales opportunities to consistently achieve performance targets.
- Enhanced product knowledge amongst doctors and pharmacists through detailed presentations.
- Updated sales databases with current, accurate client information.
- Followed up on leads generated from conferences, establishing potential new clients.
- Communicated effectively with healthcare professionals to promote pharmaceutical products.
- Attended national and regional medical conferences for networking opportunities.
- Cultivated positive new relationships with prospective customers across varied communication channels.
- Generate reports on sales, providing relevant information to track sales progress and inform future strategies.
- Presented new product lines to key medical and healthcare professionals.
- Organised regular meetings with healthcare professionals for effective product promotion.
- Liaised with medical staff whilst promoting benefits of new drugs.
- Set up appointments with potential and current customers to discuss new products and services.
Master pharmacist
Pharmacy No. 3092-НА, "ANA – Ana Arshinkova"
Sofia, Sofia-Capital
02.2005 - 04.2006
- Sale of OTC and Rx drugs, narcotics and high level of risk medicines, cosmetics, sanitary products, patient consultation and medical advice, processing prescriptions of the National Health Insurance Fund
- Retail Drug distribution.
- Improved patient satisfaction with thorough advice on over-the-counter treatments.
- Maintained a clean and organised pharmacy, enhancing efficiency within the workplace.
- Kept accurate records of all dispensed items, adhering strictly to legal requirements.
- Established clear and effective customer service policies to increase satisfaction and pharmacy loyalty.
- Informed patients of best methods for managing chronic conditions and most appropriate ways for taking prescriptions.
- Supplied non-prescription medicines, diagnostic and therapeutic aids, providing advice to customers on effective usage.
- Maintained accurate and detailed records of all medications processed through pharmacy.
- Educated patients on optimal dosage, methods of administration and drug compatibility prior to dispensing medications.
- Managed pharmacy budgets through inventory management.
- Provided comprehensive consultations with patients for improved understanding of their medication regimes.
- Ensured accuracy in dispensing prescriptions, ensuring safety for patients.
- Reviewed physician orders to assess prescription accuracy and safety.
- Stored medication according to specific temperature instructions.
- Stayed up-to-date on NHS payment and exemption rules.
Pharmacist
Ceiba – chain pharmacies and drugstores
Sofia, Sofia-Capital
02.2004 - 09.2004
- Sale of OTC and Rx drugs, cosmetics, sanitary products, patient consultation and medical advice, processing prescription documentation of the National Health Insurance Fund, drug orders and assuring proper drug supply of the pharmacy, inventory conducting
- Wholesale and retail drug distribution.
- Provided patients with pamphlets and verbal instructions about taking, handling and storing medications.
- Ordered and purchased pharmaceutical supplies, medical supplies and drugs.
- Enhanced patient care by providing accurate medication information and advice.
- Managed pharmacy budgets through inventory management.
- Optimised workflow processes to enhance productivity within the team.
- Completed detailed pharmaceutical research to ensure up-to-date knowledge of new medications.
- Supplied non-prescription medicines, diagnostic and therapeutic aids, providing advice to customers on effective usage.
- Undertook regular continuing professional development activities to maintain high professional standards.
- Checked dosages carefully prior to dispensing prescriptions; ensured patient safety.
- Advised patients on potential side effects or interactions with other drugs; increased awareness.
- Provided comprehensive consultations with patients for improved understanding of their medication regimes.
- Managed stock effectively, preventing shortages of key medications.
- Maintained a clean and organised pharmacy, enhancing efficiency within the workplace.
- Collaborated with healthcare professionals to provide optimal patient care.
- Kept accurate records of all dispensed items, adhering strictly to legal requirements.
- Maintained accurate and detailed records of all medications processed through pharmacy.
- Worked with other healthcare professionals to review quality of drugs.
- Minimised errors in prescription handling through meticulous attention to detail.
Education
Pharmaceutical industry, Health Technology
Bulgarian Association of Drug Information
SofiaMaster of Pharmacy -
Medical university, Faculty of Pharmacy
Sofia, Bulgaria12.2004
Secondary education - German language
91 German language high school
Sofia, Bulgaria06.1999
Skills
- Attention to detail
- Presentation excellence
- Client relationship building
- Data collection and analysis
- Product lifecycle management
- Market research
- Project budgeting
- Product lifecycle knowledge
- Client Relationship Management
- Product launch expertise
- Quality control processes
- Strategic thinking
- Lecturer skills
Personal Information
- Date of birth: 01/13/80
- Gender: Female
- Nationality: Bulgarian
- Driving licence: Category B
Additional Information
Reiterated lector at the educational seminars of Bulgarian Association for Drug Information (BADI), Internal project leader for the national Medical devices register in BG 2013, Various projects in RA from different clients from 2018 - currently, Attended various educational seminars of Forum institute, Germany, EDQM, BADI, Member of the Bulgarian Association for Drug Information (BADI) and the BG Pharmacist professionals trade union
Languages
Bulgarian
Proficient (C2)
English
Advanced (C1)
German
Intermediate
Russian
Intermediate
Custom Section
Regulatory affairs and Pharmacovigilance consultant, Pharmaceuticals, Medical devices, Foods
Interests
Outdoor sport activities, Winter sports: snowboarding, skiing, skating
Psychology and self development programs
Timeline
Regulatory affairs and Pharmacovigilance consultant
RayaPharm Ltd.
09.2019 - 02.2026
Regulatory Affairs manager
Kohne Pharma GmbH
06.2017 - 10.2019
Regulatory affairs and Pharmacovigilance manager
Freelance consultant
09.2015 - 06.2017
Regulatory affairs manager
B.Braun Medical Ltd.
08.2007 - 11.2014
Sales expert and representative
KRKA Trade representation office
01.2007 - 06.2007
Medical representative
Ranbaxy Laboratories Limited
06.2006 - 12.2006
Master pharmacist
Pharmacy No. 3092-НА, "ANA – Ana Arshinkova"
02.2005 - 04.2006
Pharmacist
Ceiba – chain pharmacies and drugstores
02.2004 - 09.2004
Secondary education - German language
91 German language high school
Pharmaceutical industry, Health Technology
Bulgarian Association of Drug Information
Master of Pharmacy -
Medical university, Faculty of Pharmacy