Работа: Поэт, писатель, литературный работник Продажа фармацевтической продукции, лекарственных препаратов: 3 вакансии

Key Responsibilities:

- Preparing, coordinating and submitting regulatory applications to the local health authority.

- Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.

- Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.

- Supports tender operations by timely supply of accurate regulatory documents.

- Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.

- Serves as regulatory consultant to marketing team and government regulatory agencies.

- Complete the mandatory Quality training subject to the defined timeline.

- Ensure compliance with internal Quality system and policy.

Requirement:

- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

- Establishes and promotes a work environment that supports the Quality Policy and Quality System.

- English language: Advanced level.

Employment: Полная занятость

Schedule: Полный день

Experience: 1-3 года

Компания: ГЕТ ЭКСПЕРТС РЕКРУТМЕНТ

Our client - innovative multinational company of medical devices - is looking for a Regulatory Affairs Specialist.

KEY RESPONSIBILITIES:

- Provides input on regulatory-related issues associated with compliance and achieving the business plan.

- Prioritize and plan on product registration for his/her respective product lines.

- Preparing, coordinating and submitting regulatory applications to the local health authority.

- Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.

- Provide the management team with regular updates on product registration.

- Ensure product registrations are reviewed and renewed as required.

- Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.

- Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.

- Supports tender operations by timely supply of accurate regulatory documents.

- Establishes relationships with local medical device invitro industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.

- Establish and maintain a good working relationship with reg . . . . .

. . . . . Код вакансии: 116-294499788 - показать описание вакансии полностью >>

Our client - foreign growing pharma-company is looking for Regulatory Affairs Specialist (Russia and CIS).

Responsibilities:

- Registration of medicinal products, writing drafts of normative documentation;

- Ensuring the translation of documentation necessary for the submission of dossiers to regulatory authorities;

- Submission of documents to regulatory authorities, interaction with experts (correspondence by e-mail, telephone conversations);

- Regular information the management about the stages of registration and changes required;

- Tracking the correctness of the information entered in the State Register of Medicines.

Requirements:

- High pharmaceutical, chemical biological or medical education.

- Relevant experience in foreign company from 2 years.

- Advanced level of English.

Company offers:

- Competiitve level of salary.

- Medical insurance, meal allowance.

- Gybrid work format.

Employment: Полная занятость

Schedule: Полный день

Experience: 1-3 года

Зарплата: от 160000 до 180000 RUR

Компания: Coleman Group