Regulatory Affairs Manager, Stockholm

Job description
Do you have solid experience of working in regulatory affairs? Then we have an exciting assignment for you! Randstad Life Sciences is now looking for a Senior Regulatory Affairs Manager for a consulting assignment in Stockholm. The focus of the role is work with products under development for a company in the pharmaceutical industry.
Randstad Life Sciences are specialists in science. As a consultant with us, you get a competitive salary, benefits and collectively agreements. Your consulting manager, who is always close at hand, ensures that you get varied and developing assignments. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Responsibilities
You will be part of an established team of experienced colleagues, where the main focus in the role is to ensure documentation for products under development of drugs in accordance with current regulatory requirements.
You will:
• Be responsible for coordinating and submitting applications to the authorities
• Be an expert on processes, applications and regulatory environment to build the regulatory strategy together with the expert teams
• Provide generalist comments on the content of regulatory applications
• Be a regulatory representative in the Projects/Products Teams 
• Cooperate with authorities, partners, regulatory consultants and other departments 
• Develop and update regulatory SOPs and participate in operational excellence work, if applicable
• Provide regulatory input to project and product forecasts

Working hours
Full time and daytime. The desired start is as soon as possible and the assignment is initially 6 months with a good chance of extension. Most of the work is done remotely from home.

Qualifications
We believe that you are:
• A strong team-player with collaborative, respectful and flexible attitude and high engagement
• Able to collaborate with different parties both external and internal
• Able to and enjoys working in a volatile environment 
• Highly self-motivated and able to drive activities
• Have excellent communication skills 
We see that you:
• Have a university degree in Life Sciences
• Have at least 5 years’ experience from pharmaceutical industry or competent authority (registration, development, maintenance). 
• Have regulatory affairs knowledge
• Are fluent in English

For this assignment, it is very meritorious if you have:
• experience of working with clinical development
• experience of working with biotechnological products
• experience in immunology
• experience of regulatory requirements in markets outside EU and US
• knowledge of other languages than Swedish and English

We attach great importance to personal suitability. For us, it is important that all skills in the labor market are utilized. We welcome all applicants and strive for diversity.
We also welcome companies that are interested in joining as subcontractors to Randstad, to apply.

Application
Last application date is 2020-11-23, selection and interviews will be ongoing. The position may be filled before the last application date, therefore, apply as soon as possible.
For more information: Martina Altman, Talent Sourcer, martina.altman@randstad.se
Due to GDPR regulations, no applications will be handled through email.

About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!