We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities? Do you have experience within Regulatory Affairs and have the desire to work as a consultant? Then, PharmaLex is your career opportunity.
Our Regulatory Affairs team in Oslo, Norway is growing, and we are looking for a new team member:
Regulatory Affairs Senior Manager
- Building a client portfolio within Regulatory Affairs in Norway
- Planning and conducting authorization procedures in the EU (MRP, DCP, CP and purely national procedures) and in emerging markets as well as lifecycle management procedures (variations, renewals, MAH transfers, etc.) worldwide
- General guidance (consultancy) of PharmaLex staff and 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
- Training and supervising of new and/or junior colleagues
- University degree in pharmacy or other natural sciences
- At least 5-10 years of professional experience in drug licensing with a focus on EU
Experience with Launch Management, Labelling Management, Clinical Trial Applications and all relevant admission procedures in EU countries
- Known experience in business to business sale is an advantage
- You have experience in choosing the correct strategies for registration procedures in relation to new applications as well as variations.
- You can assess existing registration documentation and detect deficiencies as well as manage any subsequent updates in cooperation with our clients.
- Sound knowledge of current drug and regulatory requirements (EU)
- Structured, analytical, systematic and independent manner
- Ability to manage internal and external (client) relationships on operational as well as client's team lead level
- Experienced user of the MS-Office package, Adobe Acrobat and database systems
- English and Norwegian language fluency, written and spoken
- External business interaction with clients and internal collaboration within the PharmaLex organization and within several areas of the pharmaceutical industry
- Broad range of initiatives for personal development and professional training
- A friendly and open-minded work environment in a global organization
PharmaLex is one of the leading service companies for the Pharmaceutical Industry globally. We guide and assist our clients with various tasks from early strategic planning activities and non-clinical requirements to clinical development, through regulatory submission processes and finally to market approval and product maintenance post-launch activities. PharmaLex has local presence and global reach with 800+ specialists in 31 offices across the world.
For further information please don’t hesitate to contact us:
Manager Director PharmaLex Norway
+47 22 23 88 80
Agencies only by prior agreement for the specific job opportunity.