Regulatory Affairs Consultant (REF7777V)

Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

ProPharma Group Sweden is located in central Stockholm with a smaller site in Malmö, south of Sweden. As a result of the continuous growth of our company, we are now looking to recruit a Regulatory Affairs Consultant to our Regulatory Affairs Division. Location could be either Stockholm or Malmö.

Job Description

In the role as Regulatory Affairs Consultant you will be working on projects from a variety of Pharmaceutical, Biotechnology and Medical Device companies. On the projects you will be dealing with challenging and varied tasks that requires you to be result and client orientated and to display excellent interpersonal skills. At the same time you will have the opportunity to actively participate in the company’s continued development.

The work may include, but is not limited to:
Working with Regulatory Affairs, primarily on a local level, with focus on the Nordic countries (Sweden, Denmark, Norway, Finland and Iceland).

Regular contact with health authorities

Regulatory intelligence

Local regulatory advice

New registrations/variations/MAH-transfer applications

Launch preparations

Local database updates

Update/translation of product information

Review of artwork

Updates to compendiums.

The position can be based either in Stockholm or in Malmö.

Qualifications

Having an open eye for the needs of your customers and the ability to adjust to these needs.

Able to work to deadlines and solving issues in a pragmatic and proactive way.

Ensuring you are able and willing to dig into the details yet keeping an eye on the overall goal of the project.

1-2 years of experience in Regulatory Affairs.

MSc in Pharmacy, or equivalent.

Excellent communication skills (oral and written) in both Swedish and English language

Additional Information

All candidates must be legally eligible to work in Sweden.

Knowledge in local regualtory affairs. Language skills in one or several Nordic languages.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***