Junior Specialist Regulatory Affairs Animal Health Bulgaria- София

Описание

GI Group is an Italian company, present in 3 continents. It is one of the world’s leading companies providing a full range of HR Services. We offer Temporary, Permanent and Professional Staffing Services, Search & Selection and Executive Search as well as Outsourcing, Training, Outplacement and HR Consultancy. It is our mission to contribute to the evolution of the labor market and to emphasis the personal and social value of work.

For our client, America's largest pharmaceutical company producing innovative drugs and vaccines against some of humanity's most challenging diseases and the world's second largest and global leader in consumer and pet products, is looking to hire:

Junior Specialist Regulatory Affairs Animal Health Bulgaria

Main responsibilities:

Coordination of regulatory activities for vaccines and pharmaceuticals in Bulgaria in cooperation with Business operations and Global Regulatory department;
Timely preparation and submission of new registrations and all other related regulatory submission e.g. variations, renewals to the authorities of the cluster;
Cooperation with relevant departments within MSD AH Global Regulatory Affairs for responding to the requests of the regulatory authorities during closures of the procedures;
Responsible for preparation and revision of country-specific packaging material according the approved registration within the company labelling software ARTIS in close collaboration and in alignment with the business operation;
Timely information of marketing and logistics concerning changes associated with packaging updates and other product related changes;
Close collaboration with marketing and logistics during whole product lifecycle and especially during product introduction on the market;
Regulatory promotional review of marketing material foreseen for the Bulgarian market including applications to Bulgarian authorities for approval;
Following the MSD AH regulatory affairs policies and procedures and country regulations to ensure that regulatory compliance is maintained.

Key requirements:
Scientific degree (veterinarian, pharmacist, biologist or similar);
Preferable knowledge in Regulatory Affairs and European legislation, but not mandatory;
Very good knowledge of Bulgarian and English;
Flexible, meticulous, careful and precise working within the imposed timeframe;
Good communication and inter-personal skills;
Good organizational skills and can work independently in a team and works result driven;
Takes initiative and is a good team player;
Proven problem-solving skills;
Good computer skills including knowledge of MS Office.
What we offer:
Additional health insurance;
BGN 50 transport costs;
Multisport card fully paid for by the company;
25 days leave;
Home office;
Standard working hours (9-18), but may have a floating start and end.

In case your professional qualification corresponds to the above requirements and you wish to join our client's growing team, please apply with your CV in English!

All applications will be treated in the full confidentiality. Only the short-listed candidates will be contacted!

Gi Group is licensed by MLSP, license N 2348/18.09.2017, indefinite.
ДЖИ АЙ ГРУП ЕООД

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:

Категория:

Ветеринарна медицина

Държава:

България

Населено място:

Гр. София

Адрес:

бул. Ал. Стамболийски 84, ет.6

Дата:

24.01.2024

Организация:

Gi Group
Фирма/Организация - Директно търсеща служители

Детайли за организацията:

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