We are growing, grow with us!
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.
Regulatory Affairs Consultant
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.
We are looking for someone with proven work experience within Regulatory Affairs as well as:
- 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
We offer you
- Exciting and varied challenges in a friendly team, as well as many opportunities for personal development and job training
- Flexible working hours based on trust
PharmaLex is one of the leading service providers for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance, and development consulting. We are specialised in effectively designing all aspects of drug and medicinal product registrations - ranging from early development and market entry to product maintenance activities.
If you are interested in joining our team we are looking forward to receive your application documents. For further information please don’t hesitate to contact us:
Managing Director, PharmaLex Sweden
Agencies only by prior agreement for the specific job opportunity.