We are again partnering with a EQL Pharma – an entrepreneurial pharmaceutical company focusing on simplicity and efficiency to be able to deliver cost-efficient medicines of highest quality to pharmacies and hospitals, primarily in the Nordic region.
The company is growing in a rapid speed, and we are looking for their next star, i.e., a Regulatory Affairs Manager , to join their internal team in Lund.
The company conducts extensive development activities in collaboration with partners in Asia, Europe and India. The strategy is to develop generic medicines in areas where the competition is limited, so-called niche generics. The focus is not on specific therapeutic areas, but rather on the opportunities that can be identified in the Nordic market for prescription medicines sold in pharmacies or used in hospitals.
The entire business is based on EQL Pharma delivering the cheapest medicines to pharmacies and hospitals, in this way daily lowering the cost of high-quality drugs for patients and society.
Main tasks:
Regulatory Affairs
– 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
– Responsible for product information (create/update SmPC/PILs, translations) and artworks for EQL Pharma´s products in the Nordic countries
– Coordinate and act as contact person in outlicencing projects (coordinating due diligence from other parties, responding to questions, participating in cross functional meetings)
– Contribute to creation and improvement of internal RA processes and working instructions
The work also includes new applications. EQL themselves is responsible for the advanced work of creating the package in terms of classifying and putting together variations, making groupings, etc. All strategic work is done at the EQL office in Lund, of which you are an important part.
If desired, the position also can be expanded with PV-related tasks (around 30 %)
– Internal contact person at EQL Pharma for QPPV and dQPPV at outsorced to external PV service provider
– Ensuring that all MAH´s PV requirements are complied with
– Maintain and update internal SOPs and the PSMF
– Participate in external and internal audits and authority PV inspections
– Establish and maintenance of Pharmacovigilance Agreements with relevant Suppliers and PV Service providers
– Perform Risk Assessments of Suppliers/PV Service Providers and ensuring that there is an updated Audit Plan in place
– Documentation, assessment and investigation of deviations within the PV area
Required experience:
– At least 3 years experience of RA – including experience of classification and compilation of variation application packages and renewals (not only submission of “complete” package prepared by head office)
– Experience in eCTD is a big advantage
– Experience within Pharmacovigilance is a big advantage
– Fluent in Swedish (or other Nordic language) and English
– Degree within pharmacy or life-science
Personality:
– “Doer” mentality – able to work independently and take ownership of tasks
– The right candidate has a flexible and prestigeless personality
– Enjoys working in a small, quickly growing company with short decision paths and where a lot of things are going on at the same time
– The role includes cooperation with India, Indonesia and several different European countries – an interest and understanding for different cultures is required
Why?
EQL is a small, flexible and dynamically company with short decision-making paths that offers a wide range of areas of responsibility and where over time you also become broad in your role and a lot of accountability. There is a very good atmosphere at the company where the level of ambition is high within the expert teams, where good collaborations prevail and where the learning curve is said to be high. The company faces a bright future and has a good business plan where in the long term the company will grow on a large scale by an average of 40%/year.
Do not miss this chance to take part in an exciting growth journey and to contribute to the development of cost-efficient pharmaceuticals for the Nordic markets.
Application
For further information, do reach out to Kristina Edholm (Sr Recruitment Manager). Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
Read more about Regulatory Affairs Manager here!
