Posted on 31st March 2020
Regulatory Affairs Manager (Nordics and Baltics)
About Curium Prague, Czech Republic
Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.
Summary of Position
This position will have an overall responsibility for operating a quality and pharmacovigilance system in these countries in collaboration with regional and corporate personnel. This includes adverse events reporting, product complaints and product recalls on a country and regional level in cooperation with local and corporate personnel, and maintaining a quality system for pharmacovigilance matters. Acting as the NRPP (National Responsible Person Pharmacovigilance).
Furthermore, the position shall ensure the compliance with regards to Good Distribution Practice for the products that are distributed in the Nordic countries.
In addition, maintain/update registration status in collaboration with regional and corporate personnel of products by timely submission of variations. The position supports the pharmaceutical product family, ie nuclear medicine products. Ensures compliance with national regulations in the Nordic countries and provides interpretations of these to other functional areas.
Actively participates in regulatory, pharmacovigilance and GDP forums and keep company abreast of changing regulatory laws and requirements. Responsible Pharmacist for the Nordic countries.
1) Prepare and coordinate documents for regulatory submission in the Nordic countries.
2) Provides regulatory impact assessments and data for countries under his/her responsibility when requested by Regulatory Affairs Europe.
3) Keeps abreast of competent authority regulations in the Nordic countries in order to communicate relevant policy changes to management in a timely manner and provide plans for complying with new requirements.
4) Acts as the company representative with national medical product agencies/radiation safety agencies to obtain approvals for marketing authorizations, variations, wholesale licenses and radiation safety licenses.
5) Participates in applicable industry working groups and committees and communicates industry movement and potential regulatory changes to the local operating company.
6) Reviews, assists in the development and locally implements relevant SOPs related to pharmacovigilance, product complaint, product recall, medical enquiries, GDP etc. for the pharmaceutical product family.
7) Be the National Responsible Person (NRPP) for Pharmacovigilance for the Nordic countries, coordinating adverse drug reaction reporting for events originating from the Nordic countries to European Drug safety department.
8) Coordinates product recalls for the Scandinavian countries and providing relevant reports regarding the recalls to competent authority.
9) Assist in obtaining answers to medical enquiries originating in the Nordic countries under his/her responsibility.
10) Handles ad-hoc projects or tasks that may arise from time to time.
11) Liaises and, if applicable, meets with representatives from national authorities regarding planned or pending regulatory filings.
12) The Responsible Pharmacist has the overall responsibility for the pharmaceutical activity required for the local wholesale license. The responsible Pharmacist shall ensure that the company complies with local regulations on distribution of Curium Netherlands and Cis Bio International pharmaceutical products as defined in EU GDP regulation.
13) Responsible for product release checking for radiopharmaceuticals imported to Sweden.
* Master Degree in Pharmacy
* Minimum 3-5 years of experience in regulatory/pharmacovigilance/quality affairs management within the Nordic countries
* Essential understanding in pharmaceuticals and the pharmaceutical industry processes
* Excellent analytical, planning and organisational skills
* Ability to develop, implement and manage Quality system, including SOPs
* Excellent written and verbal communication skills
* Fluency in English and Swedish, Finnish appreciated
* Computer literacy (MS Office tools), good understanding of databases and document management
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Equal Opportunity Employer
Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.