Regulatory Affairs in Pharma or MedTech Industry, Gothenburg

Job description
For future consultant assignments within the Pharmaceutical or MedTech industry we are now looking for new employees who will work with Regulatory Affairs. This is an exciting opportunity for you who have experience from Regulatory Affairs and want to pursue your career within that field.

Responsibilities
Regulatory Affairs are responsible for project management and coordination of the content of all regulatory submissions sent to health authorities and ensure that products meet all legal requirements, both regarding new products as well as for new indications, new markets license renewal, etc. A role within regulatory affairs may include:
Prepare and deliver regulatory operational plans for allocated projects/products. 
Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
Ensure high technical quality of regulatory documentation submitted to health authorities.
Work flexibly within and across different areas to provide broad regulatory support to ensure the delivery of product team and business objectives. 
Identify potential regulatory risks to the operational plans, and propose options to mitigate risks. 
Contribute to solutions to regulatory issues. 


Qualifications
Minimum Requirements 
Scientific degree e.g. Engineering, Biotechnology, Molecular Biology, Pharmacist
At least 2 years of experience from the Pharmaceutical industry or MedTech industry
Experience of working with Regulatory Affairs in the Pharmaceutical or MedTech industry
Excellent written and verbal communication skills
Fluent in written and spoken English
Strong collaboration skills

 
Preferred experience/requirements
Good knowledge of regulatory requirements connected to the Pharma and/or MedTech industry
Comprehensive understanding of the pharmaceutical/drug development process or development process of MedTech products
Fluent in written and spoken Swedish



Personal Qualities 
We put high importance in personal qualities. Candidates should possess good social skills and be strong team players. You should be able to work independently, take own initiatives and have a positive, goal oriented and problem solving attitude. It is essential to have good organizational and communication skills.
 
For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-04-11, since selection is done continuously we prefer receiving your application as soon as possible.


For more information: Birgitta Nyström, birgitta.nystrom@randstad.se

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.


Randstad Life Sciences 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!