Regulatory Affairs Manager

Описание

ELENA MAKAROVA
MOSCOW, RUSSIA ∗MAKAROVE@YANDEX.RU ; TEL: +7-916-3717717
EXPERIENCE
November 2015 – present time Senior Regulatory Affairs Consultant, Consulting company Moscow,RF

Provide consulting services in the area of cir culation of drugs and medical devices in the following directions
• Registration of medica l devices and drugs in Russia and EAEU
• Сlinical trials application submission, get permission to Clinical trials
• Post-registration changes in the regulatory documents (RD)
• Registration of line exten sions (new dosage forms, strength, indications etc.);
• Ensure the Russian Normative Documents are updated in line with analytical
procedures from the site s
• Ensure Technical file and Operation manual are updated in line with EAEU and
Russian regulations;
• Maintenance of the communications with local MOH Departments , Roszdravnadzor,
responsible for MD, IVD, drugs, registration;
• Monitoring of registration process, timely reaction on queries from HA and other
relevant organizations;
• Adopting of changes in Regula tions of registration procedure and timely implementation
of these changes into daily process and procedures.
• Registration of substances
• Registration of medical immunobiological products
• Development of corporate design and prototype of drug packaging
• Good knowledge on the loc al procedures and regulations regarding requirements for
MD, IVD, drugs and Biologics products ( Vaccine, Gene Therapy, Cell Therapy, Monoclonal
Antibodies, Recombinant hormones/Proteins, Blood/Blood components and Tissue ).


June 2007 - November 201 5 - Country manager/Regulatory affairs manager Emergo Consulting LLC
Moscow, RF


• Function as Regulatory Project Manager on assigned projects and mentor other Regulatory Project
Managers, Co -ordinate and manage flow of information, document client and agency contacts.
• Design and complete regulatory deliverables, marketing applications, clinical trial applications etc for
assigned projects; interface with company as appropriate during process.
• Conduct critical reviews of key technical docu ments including, pre-existing regulatory dossiers, non-
clinical and clinical development plans, protocols and reports and related documentation aiming to
ensure completeness, scientific accuracy, regulatory compliance, consistency with other key documents
and ease of review.
• Provide general, development and regulatory advice for company. Arrange, participate in and report on
meetings with regulatory authorities, with managerial supervision.
• Responsible for completion of assignments on time to cost and qual ity requirements, with a proactive
approach to assignments. Contribute to time and cost estimates for projects.
• Follow company standards and policy.

December 2005- June 2007 Baxter, USA, Moscow, RF
Head of Regulatory Affairs and Pharmacovigilance Depart ment in Russia and CIS
• Provide registration, r e-registration of medicines, medical equipments and disposables in Russia and CIS
countries
• Design and complete clinical trial applications . Ensure the delivery of high quality clinical studies to
agreed timel ines and budget.
• Preparing regulatory strategy documents based on detailed analysis of technical/scientific
documentation and current knowledge of application regulations and conduct critical review of
documents, ensuring completeness, fairness, scientifi c accuracy
• Provide strategic and tactical advice to drug and equipment development staff to ensure projects are
managed, proceeded on time, and within the designated budget whilst liaising with the appropriate
regulatory body.
• Manage and conduct sample QA and verification checks on process deliverables to verify compliance to
GCP; report the results of operational QA and compliance checks and quality gates to appropriate
• Identify and manage initiatives to improve department capabilities
• Initiate efforts to generate business leads
• Maintain current knowledge of New regulatory requirements for all Baxter’s products
• Implement and develop according to new requirements Labels for all Baxter’s products
• Develop budget and reports
Supervised 5 (five) persons

2002 - 2005 IPSEN, France, Moscow, RF
Regulatory Affairs Manager
Develop and implement global regulatory strategy.
• Analyze laws, regulations and guidelines for compliance requirements of Authorities
• Negotiate with Government Health Authorities during the reg ulatory procedures
• Provide registration, re -registration and certification of medicines in Russia and CIS countries
• Provide expert regulatory advice for assigned projects
• Coordinate preparation, review and assembly for all documents, ensuring consistency w ith European
standards
• Provide clinical trail design ( III, IV), conduct and documentation are in compliance with GCPs
Supervised 1 (one) person.

2000- 2002 Merck Sharps & Dohme Idea, Inc. Switzerland
Moscow, RF
Regulatory Affairs Manager
• Managed scheduling and submission of the regulatory documents to Government Health Authorities

and other authorities.
• Coordinated with Government Health Authorities, preparation and implementation of controlled
documents.
• Provided registration of medicine s
• Coordinated preparation, review and assembly for all documents, ensuring consistency with European
and USA standards
• Prepared the instructions for specialists and patients.
• Implemented and maintained labels and packs(packaging development) according to the requirements
of the Authorities.
Supervised 1 (one) person.

1998- 2000 Searle Pharma LLC factory - affiliation to Monsanto Corporation (Pharmacia)
Moscow, RF
Regulatory Affairs Manager
• Designed and implemented global file according to the standards and requirements of the Government
Health Authorities
• Provided registration of medicines in Russia and CIS countries.
• Prepared the instructions for specialists and patients.
Supervised 1 (one) person.
1995- 1998 Hemofarm, Yugoslavian pharmaceutical company Moscow, RF
Regulatory Affairs Manager
• Provided registration of medicines in Russia and CIS countries( implemented global file, submitted to
Authorities, coordinated with Authorities) .
• Implement marketing research for new launch products in Russia
• Develop supply and distribution chain for imported finished products
• Organize Training for Medical Representatives on Sales and Introduction of New Launch Products
Supervised 3 (three) persons.
EDUCATION

2002- 2003 The Russian Academy of Foreign Tr ade, Moscow,RF
Management of foreign trade, specialize in management

2003- 2004 The Russian Academy of Foreign Trade, Moscow,RF
Master of Business Administration
, Marketing
1985- 1990 I M Sechenov Moscow Medical Academy, Moscow,RF
DOCTOR OF PHARMACY
Specialize in pharmacy and chemistry

COURSES AND TRAININGS
June 2003 RF, Moscow

Pharmaceutical Regulatory Training Course (arranged by FDA)
May 2001 Belgium, Brussels
Regulatory Affairs Mana gers EU Training
April 2000 USA, Chicago
Worldwide regulatory affairs training
November 1999 RF, Moscow
Presentations and negotiations skills
March 1999 RF, Moscow
Good clinical practice for investigators
LANGUAGES
Good English (oral and written)
SPECIAL SKILLS
PC: Wo rd, Excel, Power Point, Acrobat
Driving License “B”
PERSONAL INFORMATION
Skills: Analytical, organizational and tracking, co -ordination and problem solving skills, flexibility and
creativity, team spirit , positive thinking
Age: 54
Marital Status: Divorced
References: will be provided upon request