Global Regulatory Affairs Manager

We are looking for a Global Regulatory Affairs Manager for a consulting assignment at our customer, a biopharmaceutical company in Stockholm. You will be the professional regulatory support for a wide portfolio of products and partners, which makes the everyday work various and stimulating. Do you have experience from the pharmaceutical industry or competent authority and regulatory affairs knowledge? Please don’t hesitate and submit your application today!


Key Responsibilities:
• Regulatory responsible for Sobi and / or partner Products.
• Responsible for coordinating and submitting applications and post-marketing obligations to the authorities in different markets internationally
• Be an expert on processes, applications and regulatory environment to achieve and maintain marketing authorizations
• Provide generalist comments on the content of regulatory applications
• Be regulatory representative in the Core Projects/Product Teams, if applicable
• Cooperate with authorities, partners, regulatory consultants and other departments within Sobi
• Develop and update regulatory SOPs
• Provide regulatory input to project and product forecasts

Qualifications:
• Degree in Life Sciences
• Experience from pharmaceutical industry or competent authority (registration, development, maintenance). Preferably more than 3 years of experience from pharmaceutical industry or competent authority (registration, development, maintenance). Experience working with markets outside EU and US is an advantage.
• Regulatory Affairs knowledge
• Fluency in Swedish, English, other languages is an upside but not required

Personal attributes:
• Strong team-player with collaborative, respectful and flexible attitude and high engagement.
• Excellent communication skills