International Regulatory Affairs Manager

Sobi

Stockholm
Permanent
Heltid

14 dagar sedan
Snabb ansökan

Company DescriptionSobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.Job DescriptionOne of Sobi’s four strategic pillars is to “Go Global”. The Manager, Regulatory Affairs International supports our ambitious geographical expansion plans. Sobi is seeking to register some of our existing portfolio into new territories and to register several of our development projects into the international region. This role is key to driving both the Regulatory strategy and execution.Key responsibilities

Represent International region in Global Regulatory Team and other cross-functional forums, for assigned products
Develop International regulatory strategies and filing plans, in partnership with the Global Regulatory Lead, and country leads, for assigned products in development
Plan and create a core dossier for International, in partnership with cross-functional teams, for assigned products
Develop regulatory strategies in assigned countries, in partnership with local Regulatory teams
Manage, plan and direct all aspects for the successful preparation, submission and timely approval of marketing applications and post-approval management for assigned countries
Provide strategic guidance on regulations and changes in assigned countries
Support interactions with Health Authorities in assigned countries

Qualifications

A University Degree in Life Sciences is required with 5 to 7 years of industry experience, of which at least 3 years of experience within Regulatory Affairs (registration, development, maintenance)
Experience of regulatory requirements in countries outside the US and Europe
Very good knowledge in written and oral English is required, knowledge of any other languages would be an asset
Experience from leading projects and cross-functional teams

Additional InformationPersonal Attributes

A strong team player, with the ability to work effectively in a team setting and interact with people of different cultural, seniority and functional backgrounds
Highly self-motivated and able to drive activities
Excellent communication skills
The suitable candidate should demonstrate the Sobi Values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership
Ensure exemplary behaviour, ethics and transparency within the Company and with regulatory agencies

In addition, you should live up to our core values: Ambition, Ownership, Urgency, Partnership and Care.

Sobi