Be part of our growing company!
PharmaLex is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance and development consulting. We are specialized in effectively designing all aspects of drug and medicinal product registrations - ranging from early development and market entry to product maintenance activities.
The success of our company resides in the expert knowledge and high motivation of our employees.
We are looking for motivated, committed candidates who will enjoy working both independently and in collaboration within our successful team in a challenging environment. So, if your career is much more than just a job for you but rather your passion, then come and join our successful team. Our Nordic Regulatory Affairs team in Denmark is growing, and we are looking for new team members based in Denmark.
Marketing Compliance and Regulatory Affairs Manager/Senior Manager
- Provide guidance within Marketing Compliance including advice on rules and regulations for promotion of medicinal products in the Nordic Countries
- Compliance review of physical and digital promotional and non-promotional materials
- Participate in the preparation, translation, update and review of compulsory product information for promotion material
- Act as the point of contact to ENLI on behalf of clients
- Compliance Intelligence
- Ad hoc support – provide guidance in interactions with HCP, HCP, PAG, government officials etc. so it is aligned with national codes
- Participation in regulatory processes to gain and maintain marketing authorizations (applications, renewals and variations)
- Evaluation, preparation, revision and compilation of regulatory documentation
- Planning, filling, and conducting authorization procedures in the EU (MRP, DCP, CP and purely national procedures) and potentially worldwide as well as lifecycle management procedures (variations, renewals, MAH transfers, etc.)
- Advise clients on regulatory strategy and fit this to the client’s overall business objectives
- General guidance (consultancy) 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
- Interpret and respond to regulatory questions to resolve issues
- Contribution to optimizing departmental internal processes
- Active contribution and distribution of department relevant expertise
- Experience within Marketing Compliance e.g. understanding the rules and regulations for promotion of medicinal products and preparation and review of promotional and non-promotional materials
- Experience within Regulatory Affairs e.g. evaluation, preparation and compilation of regulatory documentation and/or experience in regulatory processes (registration procedures, renewals, variation procedures)
- University degree in pharmacy or other life sciences
- Ability to implement tactical goals of customer or internal projects within daily work
- Structured, analytical, systematic and independent manner
- Capability of prioritization and processing of parallel projects and tasks
- High service orientation
- Ability to manage internal and external (client) relationships on operational as well as client’s team lead level
- Excellent team player
- Professional written and spoken communication skills with internal and external customers, colleagues and supervisors. Experienced user of the MS-Office package, Adobe Acrobat and database systems
- Language fluency in English and Danish, written and spoken
- External business interaction with clients and internal collaboration within the PharmaLex organization
- Broad range of initiatives for personal development and professional training
- Exciting and varied challenges in a friendly and openminded work environment in a global organization
If you are interested in joining our Pharmalex team we are looking forward to receive your application documents stating your earliest possible starting date any visa requirements on-line.
Agencies only by prior agreement for the specific job opportunity.