EQL Pharma (EQL) 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, with direct sales in the Nordic and other tender driven markets in Europe and by out-licensing for the other markets. EQL is based in Lund, Sweden and employs around 10 people.
EQL is specialised in developing and selling niche generics, i.e. drugs that are medically equivalent to niche original medicines, and to some extent niche originals. EQL conducts extensive development in cooperation with leading contract manufacturers and major pharmaceutical companies in Europe and Asia.
Our strategy is to build a large portfolio of niche generic medicines and niche originals in areas where the competition is limited. We do not focus on specific therapeutic areas, but rather on the opportunities we can identify in European market for prescription medicines sold in pharmacies or used in hospitals.
EQL has a signed pipeline of around 50 products and an extensive funnel of in-licensing and developmental product candidates. The company was founded in 2006 and is listed on Spotlight since 2014.
For more information about EQL, see EQL homepage, http://www.eqlpharma.com
Senior Regulatory Affairs Manager
EQL Pharma is looking for a key co-worker to join the fastest growing niche generics company in the Nordics
Company: EQL Pharma
Role: Senior Regulatory Affairs Manager
Place of residence: Lund/Malmö/Helsingborg vicinity
The role as Senior Regulatory Affairs Manager
EQL Pharma is looking for a Senior Regulatory Affairs Manager who will be responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements.
You should have an understanding and demonstrated ability to apply regulatory guidelines / regulations to successful dossier preparations, submission and maintenance. The candidate will provide project management, conduct and secure high-quality regulatory plans and interact with important internal and external stakeholders and regulatory authorities.
As the company is small, you must have a “can do” attitude and be comfortable in situations where you are hands-on. This is an opportunity to join the fastest growing niche generics company in the Nordics.
Responsibilities and main tasks
• Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
• Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy
• Provide expert regulatory input to in-licensing evaluations and due diligence activities
• Provide advice about regulations to manufacturers/scientists
• Coordinate successful submissions and approval of applications
• Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil European regulatory and quality standards
• Write comprehensible, user-friendly, clear product information leaflets and labels
• Compile and file dossiers for the Nordics but also to other medical authorities in Europe
• Liaise and negotiate with regulatory authorities
• Develop and establish policies and standards that convey the best practices in the company
• Use a variety of specialist computer applications
• MSc / PhD in a scientific discipline
• Experience from pharmaceutical industry from a regulatory affairs perspective
• Basic understanding of EU regulatory dossiers and their content
• Knowledge of Dossier applications under the DCP, MRP or National route is an advantage
• Knowledge of European pharmaceutical legislation and relevant guidelines
• Fluent in oral and written Swedish and English
• IT skills
• Experience from working with generics is an advantage
• Experience from MRP, DCP, National MA procedures and variations is an advantage
• Experience from pharmacovigilance, QA and product development is an advantage
• Ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance
• Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources
• Establishes good relationships with customers and staff
• Adapts to changing circumstances
• Strong initiation and organizational skills
• Outstanding written and oral communication skills, with ability to influence others and negotiate successful outcomes
• Strong analytical skill and technical/ scientific competence
• Attention to details and ability to appropriately assess risks and formulate risk-management strategies, including taking “the big picture” view on various options
• Team-player, able to positively influence team members at all levels with an entrepreneurial “can do” attitude
• Proactive, quick learner and independent worker able to effectively multi-task in a high achievement environment and follow issues through to conclusion
Opportunities with the role
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 also includes project management and international travelling.
For inquires and more information about the position, please contact:
Eva Runnerström or Catharina Herbertsson , Senior Recruitment consultants at PeakSearch.
email@example.com, +46 (0)701 725 379
firstname.lastname@example.org, +46 (0)706 152 772
Apply for the position at PeakSearch homepage http://www.peaksearch.se or send your cover letter together with your CV directly to either Eva or Catharina, see above.