Архив: Regulatory Manager. Алматы.

Описание

Main Purpose:

Lead Kazakh Regulatory Affairs Team; establish the company global and local processes, systems and initiatives. Ensure adherence to regulatory compliance according to local and corporate requirements. Plan and execute KZ-3 submission/approval plan, including but not limited to initial submissions and maintenance throughout product life cycle. Ensure proper communication and coordination with other departments to align regulatory activities with the commercial needs. Responsible for regulatory budget planning and execution.

Core responsibilities:

Registration activities For initial submission ensures all steps of registration process with local Health Authorities, are fulfilled according to the corporate requirements and local legislation as well as in alignment with global and local SOPs. For maintenance throughout product lifecycle ensures all steps of registration process with local Health Authorities, EPD RA and Affiliate staff, etc. are fulfilled according to the corporate requirements and local legislation as well as in alignment with global and local SOPs. Ensures registration activities are performed within approved budget for Kazakhstan, Kyrgyzstan and Mongolia.

2. Labeling and packaging activities

Local prescribing information

Ensures the Local Prescribing Information (LPIs) for the countries are created, revised, submitted and approved according to the corporate requirements and local legislation . Ensures timely submission of safety-related labeling variations according to the corporate and local requirements.

3. Artworks

Ensures the artworks components are developed and their approval process is followed up according to the corporate requirements and local legislation as well as in alignment with global and local SOPs.

4. Promotional materials

Ensure reviewing and approving of promotional materials with regards to regulatory information according to global and local SOPs.

5. Price registration​​​​​​​

6. Miscellaneous

Executes collaboration with Affiliate staff, including but not limited to: Logistics, Commercial, Marketing etc. to ensure that regulatory activities are aligned with the product supply activities and business needs. Monitors local regulatory legislation in Kazakhstan, Kyrgyzstan and Mongolia, assesses regulatory impact on business and provides management with appropriate solution/strategy. Fulfills proper and timely implementation of the company global and local processes, systems, initiatives; passes the required trainings on time. Ensure KZ RA team fulfills proper and timely all required trainings.

Requirements:

University Degree in Pharmacy, Chemistry/Biology; Preferably at least 4 years of Regulatory experience in an associated company within Health Care Industry; Fluency in English; Efficient Computer skills; Strong people management skills; Excellent communication and interpersonal skills.

График

Полная занятость, полный день

Компания

Абботт лабораториз гмбх

Опыт работы

3–6 лет

Город

Алматы

Категория

Медицина и фармацевтика