Работа: Собственная безопасность Торговля розничная, оптовая: 3 вакансии

PRIMARY PURPOSE OF THE POSITION:

Necessity to carry out RA activities in Teva company including: life cycle support for marketed products; EEU Upgrade dossiers submission; new products submission for registration; due diligence of new selections; support of other EEU/CIS countries on RA issues.

RESPONSIBILITIES:

- Registration dossiers preparation for new submissions, EEU upgrades, variations and renewals and their submission to the competent national and EEU regulatory authorities.

- Full cycle: normative documents & patient leaflets preparation.

- Taking the necessary measures to ensure compliance with the planned timing of new product registration, renewal and variations traded products.

- Realization of business correspondence with the Health Authorities pertaining to the regulation of drug products.

- Cooperation with manufacturing sites (business correspondence, regulatory strategy, timely informing etc.).

- Cooperation with related Departments of Teva company.

- Monitoring changes in the regulatory framework of regulatory processes (laws, regulations of the Government of the Russian Federation, orders, letters, etc.).

- Review of the promotional materials.

REQUIREMENTS:

- Higher pharmaceutical, chemical, bio-technological education

- At least 3 years experience in Regulatory affairs

- Experience in: Current National and EEU legisl . . . . .

. . . . . Код вакансии: 116-290734741 - показать описание вакансии полностью >>

Responsibilities:

- Registration dossiers preparation for new submissions, EAEU harmonization and upgrades, variations and renewals and their submission to the competent national and EAEU regulatory authorities.

- Full cycle: normative documents & patient leaflets preparation, collection of dossier, submission and answer to DL.

- Identification of gaps, gap assessment and taking the necessary measures to ensure compliance with the planned timing of new product registration, renewal and variations traded products.

- Realization of business correspondence with the Health Authorities pertaining to the regulation of drug products.

- Cooperation with manufacturing sites (business correspondence, regulatory strategy, timely informing etc.)/Regional RA and CMC colleagues.

- Monitoring changes in the regulatory framework of regulatory processes (laws, regulations of the Government of the Russian Federation, orders, letters, etc.) and to align RA strategy with RA line manager and business stakeholders.

- Review of the promotional materials.

- Maintenance of all RA actual data in registers and corporate systems/tools.

- Cooperation with labeling team, marketing and supply chain teams for respective licenses/products.

Requirements:

- Higher pharmaceutical, chemical, bio-technological education

- Dedicated at least 2-3 years experience in Regulatory affairs PHA requ . . . . .

. . . . . Код вакансии: 116-294621191 - показать описание вакансии полностью >>

Key responsibilities:

- Liaise with regulatory agencies and provide appropriate responses to requests from regulatory agencies

- Implement and comply with the requirements of the quality management system in the processes: self-inspection, deviation management, CAPA management

- Provide legal support for GMP inspection

- Ensure timely submission and approval of registration dossiers, registration confirmations and amendments to registration dossiers according to prescribed plans

- Participate in appropriate training to improve knowledge and professional skills

- Take charge of developing and updating written standards

Requirements:

- Postgraduate or graduate in pharmacy/biology/chemistry with considerable experience in Regulatory Affairs with managerial responsibilities

- Additional education in management is beneficial

- Knowledge of drug development process and laws, regulations and practices affecting the pharmaceutical industry

- Fluent written and speaking English

- Experience in people management; team-building and team-working skills

Employment: Полная занятость

Schedule: Полный день

Experience: 3-6 лет

Компания: ГЕТ ЭКСПЕРТС РЕКРУТМЕНТ