Regulatory Affairs Specialist- София

Описание

Gi Group is part of Gi Group Italy - one of the world’s leading companies providing services for the development of the labor market, operating in the fields of temporary and permanent staffing, search and selection, as well as a variety of complementary HR consulting activities.


For our client, a large American pharmaceutical company, we are looking for:
Regulatory Affairs Specialist

* The position is for a period of 1 year with the possibility of continuing the project.

Main responsibilities:

Maintenance of licenses for assigned products;
Ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities;
For assigned products, ensures timely preparation and maintenance of Summary of Product - Characteristics, patient package leaflets, local physician circulars, packaging material and others;
Participates in establishing and maintaining relevant Standard Operating Procedures to ensure that the current regulations are complied with;
Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.

Key requirements:

Higher degree of education specialty medicine, chemistry, biology, pharmacy;
Experience in a similar position will be considered an advantage.
Strong business acumen with fluent English;
Excellent computer skills, especially Excel and Power Point;
Organized, attention to detail, cooperative;
Demonstrate high responsibility, professionalism, meticulousness and attention to details in all matters including multitasking.

The offer:

Be part of an international company within a team with strong drive for achievement;
Additional health insurance;
Working hours : 8 hour working per day – flexible;
Remoute work;
Multi sport card;
Paid leave 25 days;
Challenging and interesting work;
Ability to build extensive knowledge and a competitive remuneration.
All candidates should be treated in full confidentiality.

Only short-listed candidates will be contacted.

Gi Group is licensed by MLSP, with permanent license N 2348, valid from 18.09.2017

Изисквания към кандидата

Езикови познания:

Трудов опит:
С професионален опит от 1 - 3г.

Образование:
Бакалавър

Ние предлагаме

Вид заетост:
Пълен работен ден

Срок на заетост:
Постоянна

Договор:

Ниво в йерархията:
Експертен персонал без ръководни функции

Трудово възнаграждение:

От 3000 до 3800 лева на месец

Категория:

Счетоводство и Одит

Държава:

България

Населено място:

Гр. София

Адрес:

бул. Ал. Стамболийски 84, ет.6

Дата:

30.10.2023

Организация:

Gi Group
Фирма/Организация - Директно търсеща служители

Детайли за организацията:

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