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Regulatory Affairs Consultant

  • Applications are considered on a rolling basis
  • Applications are considered on a rolling basis

Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? PharmaLex is one of the leading service providers for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance, and development consulting.

In Sweden we are looking for a motivated, committed colleague to join our growing Regulatory Affairs team. Our office is located in the middle of Sahlgrenska Science Park, Göteborg.

The responsibilities will be dependent on previous experience and client needs:

  • General guidance (consultancy) of customers regarding Regulatory Submissions & Labelling
  • Participation in the preparation, revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling)
  • Communication with the client and the Health Authorities
  • Regulatory planning, advising and implementation of marketing authorisation application procedures in the EU (MRP, DCP, CP, and national)
  • Regulatory life cycle management procedures (variations, renewals, MAH transfer etc.) worldwide.
  • In addition, you might be involved in projects within quality and pharmacovigilance whenever needed.

Skills & Requirements

We are looking for someone with proven work experience within Regulatory Affairs.

Requirements

  • Academic degree in pharmacy or life science
  • Well organized and sense of accuracy
  • Service minded, flexible, and committed to meeting deadlines
  • Fluency in spoken and written Swedish and English
  • Team player

About the company

PharmaLex is one of the leading service companies for the pharmaceutical industry globally and is specialized in all aspects of drugs and medical devices approval, of the development to market and any action of effective product maintenance. PharmaLex values includes international mindset, growth & learning, collaboration, quality focus, dynamic working approach and integrity & respect.

Åsa Pihlblad | Hiring Manager

I'm interested