English
About Gedeon Richter
The company was founded in 1901 by Hungarian pharmacist Gedeon Richter. Today Richter has grown to become a multinational pharmaceutical company with headquarters in Budapest. The company's products are distributed in more than 100 countries and it employs around 11,000 people worldwide.
Innovation and the research of original drug molecules have always been key elements in the Company's strategy. With 1000 employees in the field of research and development, Richter's main areas of focus are the treatment of benign gynaecological conditions and diseases of the central nervous system.
The Women's Health Division of Richter is dedicated to the development and commercialisation of innovative drugs for women's reproductive medicine. The company is one of very few in the world to offer a comprehensive portfolio of products for gynaecological conditions.
R&D activities within Women's Health focus on developing non-invasive medical treatments for common gynaecological conditions which are currently under-treated. Many of these conditions can have a severe impact on the patient's quality of life. The company has a pipeline of innovative compounds which includes several first in class molecules with development stages spanning from pre-clinical to newly licensed.
Gedeon Richter Global website – www.richter.hu
Gedeon Richter Nordics
Gedeon Richter has been in the Nordic region through its subsidiary Gedeon Richter Nordics since 2012. Gedeon Richter Nordics, whose head office is located in Stockholm, has operations in Sweden, Norway, Finland, Denmark and Iceland.
In the Nordic countries, Gedeon Richter is fully dedicated to Women’s Health – currently with products within Uterine Fibroids, Fertility, Contraception, Menopausal Hormone Therapy and Osteoporosis. The portfolio includes a wide range of products from premium priced novel treatments to generics which are exchanged at the pharmacy.
The company currently employs 26 passionate employees who are all committed to improving the lives of women. Our ambition is to set the trend within Gynecology.
Gedeon Richter is currently in a very exciting development phase where there are several new products, expanding into new disease areas (within Gynecology), that will be launched in the Nordics over the next few years. This creates great opportunities for adding value to patients, the healthcare systems and society.
Gedeon Richter Nordic website – www.gedeonrichter.se/
The company was founded in 1901 by Hungarian pharmacist Gedeon Richter. Today Richter has grown to become a multinational pharmaceutical company with headquarters in Budapest. The company's products are distributed in more than 100 countries and it employs around 11,000 people worldwide.
Innovation and the research of original drug molecules have always been key elements in the Company's strategy. With 1000 employees in the field of research and development, Richter's main areas of focus are the treatment of benign gynaecological conditions and diseases of the central nervous system.
The Women's Health Division of Richter is dedicated to the development and commercialisation of innovative drugs for women's reproductive medicine. The company is one of very few in the world to offer a comprehensive portfolio of products for gynaecological conditions.
R&D activities within Women's Health focus on developing non-invasive medical treatments for common gynaecological conditions which are currently under-treated. Many of these conditions can have a severe impact on the patient's quality of life. The company has a pipeline of innovative compounds which includes several first in class molecules with development stages spanning from pre-clinical to newly licensed.
Gedeon Richter Global website – www.richter.hu
Gedeon Richter Nordics
Gedeon Richter has been in the Nordic region through its subsidiary Gedeon Richter Nordics since 2012. Gedeon Richter Nordics, whose head office is located in Stockholm, has operations in Sweden, Norway, Finland, Denmark and Iceland.
In the Nordic countries, Gedeon Richter is fully dedicated to Women’s Health – currently with products within Uterine Fibroids, Fertility, Contraception, Menopausal Hormone Therapy and Osteoporosis. The portfolio includes a wide range of products from premium priced novel treatments to generics which are exchanged at the pharmacy.
The company currently employs 26 passionate employees who are all committed to improving the lives of women. Our ambition is to set the trend within Gynecology.
Gedeon Richter is currently in a very exciting development phase where there are several new products, expanding into new disease areas (within Gynecology), that will be launched in the Nordics over the next few years. This creates great opportunities for adding value to patients, the healthcare systems and society.
Gedeon Richter Nordic website – www.gedeonrichter.se/
Nordic Regulatory and Compliance Manager
A key position within Gedeon Richter Nordics with great opportunity to influence and develop the organization within the field of Regulatory Affairs
Job Title: Nordic Regulatory Affairs & Compliance Manager
Location: Stockholm
Main purpose of the position
• Ensure smooth regulatory processes of Gedeon Richter’s products on the Nordic market by collaborating with colleagues and authorities. Successful registrations are prerequisites for an efficient organization and the commercial success for the company
• Coordinate all other activities within regulatory affairs such as Pharmacovigilance, Medical Information and Quality Assurance with other colleagues or subcontractors
• Ensure that Gedeon Richter Nordics comply with existing marketing regulations and ethics codes
Main duties and responsibilities
You will have the responsibility for local Regulatory Affairs activities for all products in the Nordic countries with duties and responsibilities such as:
• Perform Regulatory Affairs activities:
• Review of regulatory texts, e.g. SmPC, PIL and labelling
• Review of artworks
• Update of SmPC and/or PIL in national drug databases
• Develop and update short SmPCs in line with latest changes.
• Communicate changes and distribute new and updated SmPCs and short SmPCs to relevant functions
• Understand relevant rules and regulations
• Support internal decision making based on regulations, guidelines and requirements.
• Formulate and implement required procedures in order to improve working processes in Regulatory Affairs and to ensure that regulatory compliance is maintained or enhanced
• Estimate and monitor regulatory affairs budget
Profile
Qualifications and experience
• Relevant academic degree
• Extensive and profound experience from regulatory affairs in the pharmaceutical industry is required, preferably from all Nordic countries.
• Overview general knowledge about quality assurance, medical information and drug safety is an advantage
• Previous experience as compliance officer is favourable
Language skills
• Excellent English communications skills
• Fluent in Finnish would be highly appreciated, but not a requirement
Other requirements or capabilities
• Better than average computer skills
• Occasional travel within the Nordics and Europe
Key competencies and personal characteristics
• Strong interpersonal- and relation building skills
• Strong ability to structure and organize projects
• Strong customer and business understanding
• Takes responsibility for actions, projects and people
• Takes initiative, acts with confidence and works under own direction
• Monitors and maintains quality and productivity
• Consistently achieves project goals
• Adapts to changing circumstances
• Accepts new ideas and change initiatives
• Thorough with a strong eye for details
Required skills
• Strong writing and oral communication skills
• Strong ability to structure and organize projects
• Strong customer and business understanding
Opportunities with the role
• Work in a company with a professional focus, personal team spirit, good cooperation, and a positive atmosphere
• To work in a smaller, dynamic organization with short decision paths and a large degree of autonomy, but still having the resources of a large multinational company
• Become a key player in Gedeon Richter Nordics, an expert within regulatory, a highly important field for company’s development and success in the future
• The pan-Nordic responsibility provides a wide variety of objectives and tasks, which include interaction with many different stakeholders
• Work with an attractive, expanding and innovative product portfolio with great potential within Gynecology and Women's Health
• The field of Gynecology and Women’s Health is emotionally important to authorities, customers and patients which enables strong and compelling communication
• Gedeon Richter is one of few companies committed to Gynecology and has strong long-term customer relations and a solid professional reputation
CONTACT
For more information, inquiries, interest and application regarding the Nordic Regulatory Affairs & Compliance Manager position, please contact Magnus Klingberg or Andrea Backlund, Recruitment Consultants at PeakSearch.
Apply for the position at http://www.peaksearch.se
Contact information
Magnus Klingberg, Sr Recruitment Consultant: magnus.klingberg@peaksearch.se , +46-70 678 09 92, +46 8 545 00 100.
Andrea Backlund, Recruitment Consultant: andrea.backlund@peaksearch.se , +46 70-235 67 96, +46 8-545 00 100