Tillotts Pharma AB is a pharmaceutical company with a focus on gastroenterology / inflammatory bowel disease (IBD). We have been a Nordic marketing company since the end of 2008 and our office is located in Bromma, Stockholm. The head office is in Switzerland. Tillotts Pharma is part of the Zeria Group. Zeria Pharmaceutical Co., Ltd., founded in 1955, based in Tokyo, Japan, focuses on R&D, manufacturing and sales of prescription drugs as well as OTC products. The company is listed on the First Section of Tokyo Stock Exchange (Stock code: 4559). Zeria holds a leading position within the gastroenterology field in Japan and operates internationally through a number of subsidiaries. For more information about Zeria please visit http://www.zeria.co.jp.

Three people are responsible for the Swedish market. In our office in Bromma our Nordic/Baltic Managing director, marketing assistant and registration, quality and logistics managers are situated. Two medical consultants are linked to the Nordic/Baltic marketing company. For more information concerning the organisation please see appendix I. Tillotts was started in London in the 1950s, as a family-owned pharmacy under the name Tillotts J.B. Tillott Ltd Chemists. The business gradually expanded with wholesale operations and eventually the import of medicines, especially gastric ulcer treatments.

During the 1960s, after the company was transformed into "Tillotts Laboratories Ltd", Tillott became the market leader in gastric ulcer treatment in the United Kingdom. The company acquired the global rights to Asacol® and Colpermin®, two patent-protected products for the treatment of inflammatory bowel disease and IBS, respectively.

During the 1980s, the head office was moved to Switzerland, and is still there, in Rheinfelden.
In total, Tillotts Pharma has over 300 employees in Switzerland and abroad. We are dedicated to the development, in / out licensing and marketing of innovative pharmaceutical products in gastroenterology. We successfully market our own products as well as licensed products in over 65 countries through our subsidiaries and a network of carefully selected licensing and marketing partners. We work closely with pharmaceutical research centers and universities.

In 2019, Tillotts Pharma in Sweden had sales of just over SEK 327 million. For more information about the company, visit http://www.tillotts.se or http://www.tillotts.com

 

Regulatory Affairs Manager - Nordic/Baltic

The position
The Regulatory Affairs (RA) manager is responsible for ensuring that regulatory strategies and associated activities are effectively executed to meet the business objectives and legal requirements. Responsible for coordinating all regulatory activities in the Nordics including Baltic. This role is also responsible for all Nordic/Baltic pharmacovigilance (PV) activities such as collecting adverse events for reporting to HQ and fulfill all EU PV obligations as applicable.

The RA manager will work cross-functionally with QA/logistics and with the sales/marketing teams within the geographical area of responsibility. The RA manager will work very closely to his/her counterparts at the HQ. The RA manager reports to the Nordic Managing Director.

This is an opportunity to work in a key role with a broad spectrum of responsibilities in a small pharmaceutical company and to contribute to the growth of the company. Responsibilities include different therapy areas and contact with authorities in the Nordic countries. The position also includes responsibility for assignments in relation to pharmacovigilance, project management.

Possibilities
Tillotts Pharma is a growing company in the Nordic and in the European region. In the expansion and development of the company, Tillotts Pharma maintains full focus on the human health care, which means a full commitment to deliver health to patients. This is reflected in the spirit and the positive culture that you find among Tillotts Pharma employees.

Tillotts Pharma is a dynamic company with short decision lines and a broad-based responsibility for every individual employee. That means an opportunity to influence and take initiatives that will add value to patients, healthcare and the society.

Tillotts Pharma has developed and built a solid platform for growth within gastroenterology / inflammatory bowel disease (IBD).

The right candidate will be part of an experienced and professional team with a great spirit. The Regulatory Affairs manager will report to the Nordic Managing Director and work in close collaboration with the Nordic team as well as the HQ team.

Tillotts Pharma offers continued development for all personnel and an individual development plan will be agreed upon.

Main duties and responsibilities
• Manage the activities of Regulatory Affairs ensuring the implementation of appropriate and effective regulatory strategies.
• Coordinate successful submission and approval of all applications
• 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
• Keep up-to-date with changes in regulatory legislation and guidelines
• Arrange Nordic/Baltic translations of SmPCs, PLs and labelling texts.
• Liaise and negotiate with regulatory authorities
• Ensure that submissions meet strict deadlines
• Provide advice about regulations to marketing/sales
• Maintaining/compiling adverse reaction data and add them to the global safety database at the HQ, conducting regularly safety training etc..
• Gather adverse drug reactions and safety data from people who have experienced an adverse effect, healthcare providers like physicians as well as from the marketing/sales team.
• In close cooperation with HQ develop and review mock-ups before submission and approve all artworks before implementation
• Order Vnr and barcodes
• Secure that all local databases such as the Swedish website http://www.fass.se are updated
• Nordic/Baltic:
o Coordinate common registration activities
o Coordinate common labelling/mock-ups
o Coordinate pharmacovigilance activities

Territorial responsibility
You will have a territorial responsibility for the Nordic / Baltic countries with a base at Tillotts Pharma’s office in Bromma, Stockholm.�

Working relationships
Reporting to the Managing Director for the Nordic/Baltic markets. You will have a close interaction / collaboration both with the RA and PV team at the headquarter as well as with the Nordic team.�

Contact
For inquires and more information about the position, please contact Jarl Molin Sr Recruitment Consultant at PeakSearch.
Apply for the position at http://www.peaksearch.se.

Contact details
e-mail: jarl.molin@peaksearch.se
mobile: +46 (0)70-560 20 56