Regulatory Affairs Junior Specialist, Santen Oy, Tampere
Alkuperäinen julkaisupäivä 13.2.2021
Are you ready to take your next step on your career path? Santen Oy wants to offer you the possibility to become the next Regulatory Affairs professional of the future. We are looking for a work oriented and self imposed person to be the next top performer in the field on Regulatory Affairs. If you have a degree from Pharmaceutical, Chemical or other Life-Science field and are eager to dive into the pharmaceutical and medicinal world - don´t hesitate and apply now
ABOUT THE ROLEIn this position you will be working with Regulatory Affairs Specialists and Managers supporting them to maintain and obtain marketing authorizations in whole EMEA (Europe, Middle-East and Africa) for medicinal products in line with Santen strategies, business needs and European regulatory requirements.
You are also in a key role in developing processes and managing and preparing documentation for regulatory applications.
You are offered
* A great entry-level position in the company
* Supportive and professional colleagues
* An opportunity to get valuable experience and build connections within the global company
* Great office in the center of Tampere
* Working with Regulatory Affairs Specialists and Managers preparation of regulatory plans and strategies of regulatory applications and responses effectively pursuing approvals in accordance with regulatory requirements and company goals, preparation/maintenance of the regulatory dossiers and timely updates of regulatory database of the assigned products/countries
* Informing about received marketing authorization approvals and changes in-house to relevant departments via regulatory database and other systems
* Review and approval of secondary packaging materials to ensure compliance with regulatory approved texts
* Cooperate with internal and external partners and authorities to maintain marketing authorizations
* Develop processes and coordinate preparation of administrative regulatory documentations
* Managing invoice processing
* Courier shipments and tracking them; printing, copying and scanning documentation for applications
WE ARE LOOKING FOR
* Pharmaceutical, Chemical or other Life-Science university degree (B.Sc. or higher)
* Fluent written and spoken English and Finnish language
* Experience working with Medicinal products or Medical Devices from industry, regulatory authorities, pharmacy or academia
Other language skills or experience from regulatory affairs are seen as an asset
* Start: As soon as possible
* Work extent: Recruitment
* Location: Tampere
* Contact information: This recruitment process is conducted by Academic Work. It is a request from Santen Oy that all questions regarding the position are handled by
Our selection process is continuous and the advert may close before the recruitment process is completed if we have moved forward to the screening or interview phase.
OTHER INFORMATIONSanten Oyis a Japanese Pharmaceutical company specialized in ophthalmology. It is a specialised pharmaceutical company primarily engaged in the ophthalmic field. Its main products are drugs for glaucoma, dry eyes, eye infections and allergies. Santen is an international company, which has established a paramount position in Northern Europes prescription ophthalmic pharmaceutical market. In Europe, Santen has operated for nearly 20 years. Santen will continue its dedication to improving the eyesight and health of people worldwide, exercising the spirit of creation and innovation, as well as the scientific knowledge and organisational capabilities that we have nurtured for over 120 years since the founding of the company.
- Ilmoitusnumero: 1425720
- Työsuhde: Vakituinen työsuhde
- Työn tyyppi: Kokopäiväinen
- Hakuosoite: www-osoite
- Sijainti: Tampere