EQL Pharma was founded in 2006 and is specialized in developing and selling generic drugs, ie drugs that are medically equivalent to the original drugs whose patents have expired. The business is currently focused on prescription drugs, in several therapy areas, in the Nordic countries. EQL Pharma is based in Lund, Sweden, employs 8 people and is listed on AktieTorget.

EQL Pharma has a portfolio of 15 products and a pipeline of "first-in-class generics", i.e. products where the majority today completely lack competition. The company currently has a total of four "first-in-class generics" submitted to the authorities for approval, of which three are published.

The company’s goal is to launch at least six internally developed "first-in-class generics" until the end of 2015, to reach a total turnover of 60 million SEK in 2015. EQL Pharma’s ambition is to become the most market-driven generics and specialty pharmaceutical company in the Nordic region.

Clarithromycin EQL Pharma. Original product is called Klacid ® (Abbott) and is an antibiotic that is used in respiratory infections. The total turnover in the original stage, the markets that EQL choose to apply for, is 2.4 million SEK annually. Currently there is no other competitor than the original. EQL hope to launch the product latest in Q1 2015.

Hydroxyzine EQL Pharma. Original product Atarax ® (UCB) was developed as a first-generation antihistamine and is used today mainly in hives, itching, and anxiety. The total turnover in the original stage, the markets that EQL choose to apply for, is 34 million SEK annually. Currently there is no other competitor than the original. EQL hope to launch the product latest in Q1 2015.
 
Potassium chloride EQL Pharma. Original product is called Kaleorid ® (LEO Pharma) and is primarily used to treat or prevent low potassium ion levels (K +) in plasma during treatment with diuretics because of high blood pressure. The total turnover in the original stage, the markets that EQL choose to apply for, is 104 million SEK annually. Currently there is no other competitor than the original. EQL hope to launch the product latest in Q2 2015.
 
For more information see EQL Pharma homepage, http://www.eqlpharma.com
Regulatory Affairs and QA Director TILLSATT
The position

The RA & QA Director is responsible for ensuring that regulatory strategies and associated activities are effectively executed to meet the business objectives and legal requirements. The RA & QA Director assures quality on products and processes by establishing and enforcing quality standards within the whole company. The RA & QA Director reports to the CEO and is part of the management team.


Responsibilities and main tasks

• Manage the activities of Regulatory Affairs ensuring the implementation of appropriate and effective regulatory strategies
• Lead the Regulatory Affairs team of 3-5 people and coordinate successful submission and approval of all applications
• Manage and oversee all maintenance activities for the company products and align the Life Cycle Management strategy accordingly
• Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications
• Provide expert regulatory input to in-licensing evaluations and due diligence activities
• Plan, undertake and oversee product trials and regulatory inspections
• Keep up-to-date with changes in regulatory legislation and guidelines
• Write comprehensible, user-friendly, clear product information leaflets and labels
• Liaise and negotiate with regulatory authorities
• Develop and establish policies and standards that convey the best practices in the company
• Ensure that quality standards are met and submissions meet strict deadlines
• Review and report overall quality status to the management team
• Provide advice about regulations to manufacturers/scientists
• Project management of development of new generic products
• Use a variety of specialist computer applications


Requirements

• MSc / PhD in a scientific discipline
• 5-10 years of experience within pharmaceutical industry, with management or project leader experience in regulatory affairs
• Fluent in oral and written Swedish and English
• IT skills


Desired Skills/Experience

• Experience of a leadership or project leadership role in managing all aspects of regulatory affairs and quality assurance
• Thorough understanding and demonstrated 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
• Strong initiation and organizational skills
• Outstanding written and oral communication skills, and ability to influence others
• Attention to details and ability to appropriately assess risks and formulate risk-management strategies, including taking “the big picture” view on various options
• Excellent interpersonal and people management skills; technical/ scientific competence
• Proven leadership qualities and ability to negotiate successful outcomes
• Team-player, able to positively influence team members at all levels
• Ability to coach/ mentor staff
• Proactive, quick learner and independent worker able to effectively multi-task in a high pressure 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 work is with international focus and performed in close cooperation with several development 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. The position also includes line management tasks, project management and international travelling.


Contact

For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Recruitment consultants at PeakSearch.
catharina.herbertsson@peaksearch.se, +46 (0)706 152772
eva.runnerstrom@peaksearch.se, +46 (0)701 725379
http://www.peaksearch.se

Application: Apply for the position at http://www.peaksearch.se