EQL Pharma will become a leading Nordic pharmaceutical company by offering a diversified product portfolio of high-quality niche generics at competitive prices. EQL Pharma’s business is based on simplicity, cost-efficiency and innovation. Our decisions are based on careful cost-benefit analyses and hence we can create value for shareholders, patients and the society.



Our strategy is to build a large portfolio of generics in areas where competition is limited, so-called niche generics. We do not focus on specific therapeutic areas, but rather on the opportunities we can identify primarily in the Nordic market for prescription drugs that are sold in pharmacies or used in hospitals. These products will also be outlicensed to other European countries.



EQL Pharma currently 12 niche products on the market with a 4X larger pipeline of products under development in close collaboration with leading contract manufacturers and large pharmaceutical companies in Europe, Asia and India.



The company was founded in 2006, is listed on Spotlight (formerly Aktietorget) since 2014, based in Lund, and employs about 10 people today.



For more information about EQL, please see http://www.eqlpharma.com

 

Regulatory Affairs / Drug Safety Manager


Intressant möjlighet för dig som vill utvecklas inom Regulatory Affairs / Drug Safety på ett litet läkemedelsföretag i Lund med stor potential!

Company:
EQL Pharma
Role:
Regulatory Affairs / Drug Safety Manager
Reporting to:
Chief Executive Officer
Place of residence:
Lund/Malmö vicinity



The role as Regulatory Affairs / Drug Safety Manager


You will work within both the Regulatory Affairs and Pharmacovigilance area. The role will report to CEO and have close collaboration with the Regulatory Affairs team and external consultants.


As EQL Pharma is a small company it is necessary to have a flexible mindset as prioritisations, timelines, tasks and organisation may change. Therefore, we expect you to be proactive, organised, a quick learner and independent worker able to effectively multi-task in a high-pressure environment and follow tasks through to conclusion. In addition, you need to work thoroughly while keeping big picture perspective. You are also a team-player, able to positively influence team members at all levels with an entrepreneurial “can do” attitude. It is natural for you to build wide and effective networks of contacts inside and outside the company and relate well to people at all levels.



Responsibilities and main tasks


Regulatory

• Prepare, review and compile regulatory submissions such as variations, renewals and labelling notifications

• Prepare and translate product information such as SmPCs, leaflets and labelling documentation

• Responsible for updates of regulatory trackers, electronic files and templates

• Develop and maintain high level of understanding of guidelines, directive and laws in connection with regulatory affairs and pharmacovigilance and keep up-to-date with changes in regulatory legislation and guidelines

• Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil European regulatory and quality standards


Pharmacovigilance

• Handle adverse event reports

• Signal detection activities

• Monitor worldwide and local scientific and medical literature

• Handle medical enquiries

• Write and maintain pharmacovigilance documents like PSMF, SOPs, RMPs and PSURs

• Handle product quality complaints

• Ensure training of personnel



Requested qualifications

• BSc preferably in life science, pharmacy or equivalent

• Preferably 1-3 years of experience in regulatory affairs, pharmacovigilance or equivalent

• Fluent in oral and written Swedish and English

• IT skills



Desired Skills/Experience

• Plan activities and projects well in advance and take possible changes into consideration. Carefully monitor performance against deadlines and milestones - a structured and well-organized "Doer"

• Follow procedures, policies, regulatory requirements and safety regulations and show a great commitment to the company

• High level of communication skills, willingness to share and contribute to the organization

• Write clearly, correctly and well-structured

• Apply specialist and detailed expertise. Develop job knowledge and expertise through continual professional development.



Opportunities with the role

This is an opportunity to work in an important 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 and pharmacovigilance functions play a crucial role in this development.


You will join a small growing company, with short decision-making processes, where each employee's contribution is important for the company's development and results. The company’s office is centrally located in the heart of Lund. There are great opportunities for professional and personal development. For the right candidate there is a possibility to further develop into the role as QPPV.



Contact

For inquires and more information about the position, please contact:

Catharina Herbertsson or Eva Runnerström, Sr Recruitment consultants at PeakSearch.

catharina.herbertsson@peaksearch.se
+46 706 15 27 72

eva.runnerstrom@peaksearch.se
+46-701 72 53 79

http://www.peaksearch.se


Application

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, see above.