EQL Pharma is an entrepreneurial pharmaceutical company focusing on simplicity and efficiency at all levels of the value chain to be able to deliver a large portfolio of niche pharmaceuticals and niche originals to pharmacies and hospitals, primarily in the Nordic region.
As niche generics are not normally available for purchase, or license, as fully developed products, EQL Pharma conducts extensive development work on these in close collaboration with partners in Europe, India and China. The entry barrier for potential competitors is therefore significantly higher for these niche generics than for regular generics, as these niche products are EQL Pharma’s own products.
The strategy is to build a large portfolio of niche generic medicines and niche originals in areas where the competition is limited. EQL Pharma does not focus on specific therapeutic areas, but rather on the opportunities identified in the Nordic market for prescription medicines sold in pharmacies or used in hospitals. The entire business is based on delivering the cheapest medicines to pharmacies and hospitals, in this way daily lowering the cost of high-quality drugs for patients and society.
EQL Pharma has built a strong network of partners both in the life science cluster Medicon Valley and in the rest of Europe and the world, a network that is in constant growth and refinement as new ideas and opportunities take shape. During the last years the company has had a strong growth. Robust financing and well-thought-out analyzes are behind every investment the company makes both in its pipeline and in the expansion into new markets. Today, EQL Pharma has a signed pipeline of approximately 50 products and an extensive funnel of in-licensing and developmental product candidates.
EQL Pharma was founded in 2006 and is listed since 2014. The company is based in Lund, Sweden and employs around 23 people. The company strives to attract and retain personnel with excellence in all areas relevant to the company. High level of education, solid proven experience and personal commitment characterize the company's staff today. Last year EQL Pharma was certified as “Great Place to work”.
For more information about EQL Pharma, see the homepage, http://www.eqlpharma.com
TILLSATT - Regulatory Affairs Associate
Company: EQL Pharma AB
Position: Regulatory Affairs Associate
Reports to: Director Regulatory Affairs, Quality Assurance and Pharmacovigilance
Location: Office in Lund, south Sweden
The position as Regulatory Affairs Associate
EQL Pharma is looking for a Regulatory Affairs Associate who will support the lifecycle management activities within the regulatory affairs.
This is a role in an entrepreneurial company for someone who is willing to develop and learn new things. The ideal candidate has some previous experience from the pharmaceutical industry, if not you have a big interest in the life science sector and in regulatory affairs. You have the ability to learn how to apply regulatory guidelines / regulations. Eventually, the candidate will provide project management, interact with important internal and external stakeholders, and regulatory authorities.
The role will also include cooperation with India, Indonesia, and several different European countries – an interest and understanding for different cultures is required. Therefore, it is important that you are social and good at working with other people.
The right candidate has a flexible and prestigeless personality. At the same time, you need to be comfortable following procedures and policies as the pharma industry is a regulated business. As the company is small, you must have a “Doer” mentality and be able to work independently and take ownership of tasks. You enjoy working in a small, quickly growing company with short decision paths and where many things are going on at the same time.
This is an opportunity to join the fastest growing niche generics company in the Nordics. You will be part of a group of 5 people (RA and QA) and report to the Director Regulatory Affairs, Quality Assurance and Pharmacovigilance.
Responsibilities and main tasks
After an introduction and training within RA you will be able to perform the following tasks:
Life Cycle Management
• Responsible for product information (create/update SmPC/PILs, translations) and artworks for EQL Pharma´s products in EQL´s territory
• Manage national catalogues/databases e.g FASS, Felleskatalogen, DKMA
• Creation of variation and renewal applications to competent authorities in the Nordics and other European countries
• Submission of variation and renewal applications through the national procedure and DCP/MRP
• Assess change control case from CMOs and decide on impact on dossier/required actions
• Contribute to creation and improvement of internal RA processes and working instructions
Requested qualifications
• Degree within pharmacy or life-science
• A few years of experience from the pharma industry is an advantage
• Fluent in Swedish (or other Nordic language) and English
• IT skills
Desired Experience/Skills
• Adapts to the team and builds team spirit, listens, consults others and communicates proactively
• Writes clearly, succinctly and correctly
• Gathers comprehensive information to support decision making, manages knowledge (collects, classifies and disseminates knowledge of use to the organisation)
• Monitors and maintains quality and productivity; works in a systematic and orderly way
• Adapts to changing circumstances
• Follows procedures and policies
Opportunities with the role
EQL Pharma is in a fast growth and the company strives to give all employees a great deal of individual responsibility for their work and their work situation. This includes a great opportunity to influence and take initiatives within one's own area of responsibility, but also within other adjacent areas that may be valuable for EQL Pharma.
This is an opportunity to work in a key role with a broad spectrum of responsibilities in a small listed pharmaceutical company and to contribute to the growth of the company. The vision is to build the largest niche generics portfolio in the Nordic countries, where the regulatory function plays a crucial role in this development.
The work is with international focus and performed in close cooperation with several international development partners and licensing partners. Since the company focuses on “first-in-class generic” products, responsibilities include different therapy areas, compilation of full registration files, and direct contact with authorities, in the Nordic countries and elsewhere in Europe. The position may also include project management and some international travelling.
Contact & Application
For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Senior Recruitment consultants at PeakSearch.
E: catharina.herbertsson@peaksearch.se
M: +46 706 152 772
E: eva.runnerstrom@peaksearch.se
M: +46 701 725 379
Apply for the position at PeakSearch homepage http://www.peaksearch.se or send your cover letter together with your CV directly to either Catharina or Eva, e-mail see above.