Regulatory Affairs Director

☑ Основной блок:

Опыт работы: не требуется.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Россия, Москва.

☑ Актуальность объявления:

Это объявление № 641225 добавлено в базу данных: Суббота, 18 января 2025 года.

Дата его обновления на этом интернет-ресурсе: Воскресенье, 16 марта 2025 года.

☑ Репутация компании "Kelly Services":

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☑ Подробности о вакантном месте:

Company:

Job Responsibilities:

• Marketing authorizations:

• Ensures timely and correct submission and approval of new MA applications in close cooperation with relevant persons namely in global regulatory affairs, management, marketing, external affairs departments, research, MMD on local or global level.

• Tracks process and manages answers to requirements from the Agency on products registration and major new indications, involving negotiations to achieve the best commercial outcome.

• Designs and leads local action plans in area of MA once so is needed.

• Maintenance of MA:

• Ensures that MA are maintained through control of due time-frames and a timely implementation of necessary activities.

• Keeping updated overview on status of MA for registered products with its access availability across managerial (designated) position of the organization, in Russia and the sub-region.Communicate actions and evolution to stakeholders using described process if such exists.

• Compliance and Artwork:

• Maintain and keep updated the databank of valid versions of Summary of Product Characteristics (SPC), packaging materials and other applicable regulatory documents according to company and local standards.

• Pro-actively inform internal stakeholders on all relevant information with regard to the regulatory status of the products namely on update of SPC namely via a regular RA communication on update on the status of main activities and main RA topics to share.

• Stay in contact with MMD to ensure that updated artworks of product packaging are produced and used within legal timeframes namely by appropriate use software to generate artwork and to implement revisions of the artwork in due time.

• Guarantee consistent use of internal and external regulatory databases and systems in the country in such a way the data provided are the most up-to-date.

• Keep files and archives related to Regulatory Affairs complete and updated for requested periods.

• Establish and update the relevant Standard Operating Procedures (SOP) to secure the current internal and external requirements on Regulatory Affair of the organization are compliant and implemented in requested time-lines.

• Provide regulatory representation and support for internal and external audits related to regulatory affairs field.

• Manage RA Team.

• Other cross-functional activities.

Work Environment:

• Competitive salary, discussed face-to-face with every candidate.

• Annual bonuces.

• Corporate mobile phone.

• Volluntary medical insurance (after 1 year of work children included).

• Life insurance.

• Lunches.

Requirements:

• English in excellent written and verbal command.

• University degree in veterinary medicine, biology, pharmacy or in similar life-sciences educations.

• Satisfactory time and content of practice in regulatory affair and pharmacovigilance area.

• The incumbent must be familiar with local legislation procedures and guidelines governing pharmaceutical products.

• Excellent organizational and planning skills and be flexible to successfully handle conflicting time pressures and a large volume of work.

• Meticulous attention to detail.

• Ability and disciplined approach to lead the team and to coordinate the work of others.

• High level of diplomacy, negotiating skills but constructive assertiveness in dealing with internal and external stakeholders.

• High degree of motivation and work engagement.

• High level of presentation abilities, communications and team-cooperation.

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