Regulatory Affairs Manager, OTC

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 circulation of drugs and medical devices in the following directions
Registration of medical devices and drugs in Russia and EAEU
Post-registration changes in the regulatory documents (RD)
Registration of line extensions (new dosage forms, strength, indications etc.);
Ensure the Russian Normative Documents are updated in line with analytical procedures from the sites
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 Regulations 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 local 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 2015 - Country manager/Regulatory affairs manager Emergo Consulting LLC Moscow, RF

Helped foreign manufacturers to approve different MD and IVD: Dressings for wounds, instruments, orthopedic, dental implants, hyaluronic acid in syringes, ultrasound machines, ECG, breast implants, suture material, hemodialysis unit.

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 documents 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 quality 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 Department in Russia and CIS

I have worked with approval of Dialyzer machine, tubes, syringes, transfusion apparatus and blood and other Baxter's devices.

Provide registration, re-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 timelines 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, scientific 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 regulatory 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 with 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 medicines
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 Trade, 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 Managers 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: Word, 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