Вакансия № 1531438 на должность "Regulatory & Scientific Affairs Manager" в городе (регионе) Москва, Россия от компании "Allergan" на сайте Электронный Центр Занятости Населения

Репутация компании "Allergan" в отзывах работников:

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Обязательное требование к опыту работы искомого сотрудника: 3–6 лет.

График работы: полный день.

Тип занятости: полная занятость.

Вакансия № 1531438 добавлена в базу данных: Суббота, 13 апреля 2024 года.

Дата обновления этого объявления: Вторник, 16 апреля 2024 года.

Вакансия № 1531438 прочитана - 218 раз(а) Отправлено откликов - 0 раз(а)

Адрес вакантного места работы: Москва, улица Станиславского, 21с2.

Работодатель предложит заработную плату по результатам собеседования с соискателем работы.

JOB SUMMARY:

• Regulatory & Scientific Affairs Manager reports to Associate Director, Regulatory and Scientific Affairs, Russia
• Support the Regulatory & Scientific Affairs Team in Russia and CIS.
• Is the source of regulatory expertise for Russia and CIS in the registration, lifecycle management and post-registration support of medical device products. Develops and maintains excellent knowledge of regulatory procedures and the local environment.
• Establishes and maintains a network with trade associations, institutions, decision makers, experts and local regulatory consultancies.
• Is a key contributor to the Emerging Markets Regulatory Affairs team

  KEY DUTIES AND RESPONSIBILITIES:

• Administrative Regulatory activities in Russia
  • Provides clear, timely, constructive regulatory advice and intelligence in the registration of new products and post-registration activities in Russia.
  • Evaluates feasibility, develops regulatory strategy in conjunction with other team`s members and provide regulatory submissions in Russia
  • With the supervision of Ass. Director develops and maintains personal contacts with Reg. Authorities and other state organizations involved in regulatory expertise and quality control of Allergan`s products to ensure a clear understanding of agency requirements and effective representation of Allergan.
  • Manages relationship with external consultants involved in Allergan`s projects, including Contract Registration Agencies, Contract Research Organizations, Certification Authorities, other relevant organizations within Russia.
• Technical Regulatory activities in Russia
  • Prepares National Regulatory Applications for primary registration, implementation of variations, renewals
  • Supports and immediate paperwork on dossier compilation for regulatory submissions
  • Creates key regulatory documents for regulatory submissions (instructions, technical files, etc.)
  • Provides regulatory submissions of dossiers for registration and implementation of variations to Health Authorities
  • Performs daily communication with Health Authorities by responding on Authorities` requests and deficiency letters
  • Prepares set of documents to Health Authorities for acquisition of import license for the purpose of registration/local clinical trials
• Business Support
  • With the supervision of Ass. Director provides regulatory support and feasibility evaluation for business development and other commercial initiatives, to ensure that Russian regulatory requirements are addressed, in line with business needs

    MINIMUM REQUIREMENTS:

• Education and Experience
  • Degree in medicine, pharmacy or chemistry, ideally with a post-graduate qualification in a relevant area and/or business qualifications.
  • Extensive broad-based Regulatory Affairs experience in the medical device industry, including a successful track record in the registration and maintenance of medical device products within Russia
  • Sound knowledge of both national and European regulations and guidelines.
  • Experience in cross-functional project teams an advantage.
• Essential Skills and Abilities
  • Excellent organisational and planning ability.
  • Excellent negotiation skills with internal and external customers (e.g. Regulatory Agencies, Policy Makers).
  • Excellent communication skills, both written and verbal (in English).
  • Excellent interpersonal skills and the ability to influence others without formal authority.
  • Ability to work effectively and collaboratively across the global organisation and cross-functionally.
  • Proven managerial and leadership skills, with the ability to lead, motivate and develop staff.
  • Willingness to travel as necessary.
  • Computer literate.

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