Nordic Regulatory Affairs Manager (Detta uppdrag är avslutat)
Actavis Group is among the five leading generic pharmaceutical companies in the world, with 10,000 employees in close to 40 countries. Founded in 1956, the Group now operates across five continents and has its headquarters in Iceland.
Actavis aims to recruit and retain people that share the Company?s core values, which we call The Actavis Way. When you walk The Actavis Way you think smarter, look beyond, keep it simple, are connected and show accountability.
During 2012, Actavis will form a Nordic organization with a new head office in Stockholm, Sweden and need to recruit several professionals to newly created positions. For recruitment to positions within Pharmaceutical Affairs will Actavis collaborate with Scientific Solutions.
As a Nordic Regulatory Affairs Manager at Actavis, you will be responsible for managing Regulatory Affairs Projects in the Region. You will coordinate and support the regulatory activities for the product portfolio you are responsible for.
The position is placed at the Nordic office, Kungsholmen Stockholm.
- Preparation, submission and follow up of national applications for new marketing authorizations.
- Proof reading of regulatory texts.
- Submission of Life Cycle Management changes (variations, renewals, line extensions).
- Responsible for changes in artwork, i.e. requesting, proof reading and approval of artwork.
- Submission of national notifications and applications, such as permission for dose dispensing and OTC-switches.
- Responsible for local knowledge of applicable legislation within the responsibility area.
- Communication with local Drug Regulatory Authorities.
- Coordination with other functions such as logistics, sales, marketing and launch, regarding the regulatory work.
- Coordinate the update of various local databases in the Nordic countries, e.g. FASS, NPL, DKMAnet, Felleskatalogen.
- Higher education – preferably degree in Pharmacy, Medicine or equivalent.
- Substantial experience in a Regulatory Affairs team with very good knowledge of Nordics local legislation and guidelines.
- Good understanding of market dynamics and requirements in the Nordic region.
- Experience from an international work environment.
- Excellent skills in the English language and preferably in at least one Nordic language.
Desirable personal characteristics:
- Thorough, structured and strong organisational skills.
- Excellent team player with the ability to establish and maintain effective working team relationships.
- Have a positive and service-minded approach.
To succeed in this role you must be effective and have the ability to work independently, handle stressful situations and handle several tasks simultaneous. Furthermore you should have excellent communication skills, enjoy teamwork and be passionate about Regulatory Affairs.
You apply for this position via an external application site (follow this link), with your CV and a short personal letter.
Apply as soon as possible, no later than June 13th .
For further questions, please contact Sara Tomicic, recruitment consultant at Scientific Solutions, +46 709 73 17 47.