Regulatory Officer - Frankfurt Am Main, Deutschland - Viatris

Viatris

Geprüftes Unternehmen

Frankfurt Am Main, Deutschland

vor 2 Tagen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Mylan Germany GmbH

At VIATRIS, we see healthcare not as it is but as it should be.

We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference.

As a Regulatory Affairs Officer (M/F/d) in the local Regulatory Affairs Department Germany you will be responsible for the following tasks:

Key responsibilities for this role include:

Screening, processing, and tracking of CPP requests
Communication with CTS team regarding local particularities for CPPs
Preparation of CPPs with information from requestor.
Diligent verification of information in CPP with authorized information.
Application of CPPs at local authority in Germany
Initiation and coordination of required legalization procedure-
Cost tracking for requests, issuing at local authority and legalization.
Filing, review and distribution of print and digital-PI-texts for the marketed product portfolio of VIATRIS in Germany (patientinfo-service, SmPC TrackingSystems).
Submissions via German HA portal (PharmNet.

Bund), e.g.

reports on drug shortages, sunset clauses, product information texts (PIT) and national variations.- Maintenance of local and global database entries of VIATRIS procedures approved in Germany.- Revision and maintenance of local work instructions and standard operating procedures (SOP) in the global document management system.- Collaboration in national and international projects- Support with regulatory life cycle management of products approved and registered in Germany by VIATRIS companies such as Viatris Pharma and affiliated companies (if applicable).

The minimum qualifications for this role are:

Degree in pharmacy, biology, or chemistry
Basic knowledge of regulatory affairs (labelling / CMC)
Basic knowledge of regulatory guidelines (European and national)
Experience with database maintenance and document management systems-
Strong verbal and written communication skills (German/English)
Careful and accurate work
Work in a cross-departmental team with local and global colleagues

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.