Teva Scandinavia is part of Teva Pharmaceutical Industries Ltd, a global pharmaceutical company. Teva is among the world's 15 leading pharmaceutical companies and is the largest in the development, manufacturing and marketing of generic pharmaceuticals. Teva also develops and manufactures original drugs such as MS drugs and drugs for Parkinson’s disease. Teva has been around for more than 100 years, is listed on the stock exchange markets in New York among others. Teva has 46,000 employees with a presence in 60 countries worldwide. Teva is relatively young in Scandinavia, the operation in Sweden was established in 2004 and a few years later in Denmark and Norway. Since spring 2013 a new Scandinavian organisation is put in place.

Teva´s products are to be used mainly in outpatient care, but also hospital products, personal care products ("OTC"), medical devices and biosimilars. Examples of Teva’s original products are Copaxone® for multiple sclerosis and Azilect® for Parkinson's, the latter one marketed by Lundbeck. A new innovative drug, Spiromax® for the indications asthma and chronic obstructive pulmonary disease (COPD), will soon be launched.

Teva is proud to say that their employees are the reason for it’s sustained success. Through delegation and empowerment, Teva aims to encourage independent thinking, creativity and initiative. Further information about the company can be found on
http://www.teva.se and http://www.tevapharm.com.

 

Regulatory Affairs Manager Scandinavia

Overall Job Purpose:

Management of the Regulatory Affairs team of Teva Scandinavia.
Development of regulatory strategies for Teva Scandinavia and work with the internal development platforms to deliver on-time launches in the Scandinavian countries.
Ensure planning, submission of and follow-up on regulatory applications with the aim of timely approvals, provision of regulatory support for product launches and regulatory life cycle management of the existing portfolio.
Formulation, implementation and maintenance of a quality system within RA in order to secure, maintain and enhance regulatory compliance.

Management of the regulatory budget of Teva Scandinavia.

Main Accountabilities:

Ensure on-time regulatory approvals, in line with the forecasted launch dates
Formulate, implement and maintain RA procedures
Safeguard regulatory compliance of all products commercialized on the Scandinavian markets
Ensure timely updating of RA databases and Document Management Systems
Monitor RA expenses and ensure compliance with local RA budget
Compliance with requirements defined by Teva’s European RA units.
Build and maintain effective working relationships with Regulatory Agencies in the Scandinavian countries


Responsibilities and Main Tasks:

o Management

Provide strong leadership and clear direction to the RA team members
Secure that the RA team members have the right competences and technical skills to fulfill their job
Establish regulatory priorities and allocate resources accordingly
Ensure regular reviews on performance and implement development plans for the RA team members
Establish and monitor the regulatory budget
Ensure optimal cross-organizational cooperation

o Strategic and operational

Secure regulatory approvals of new medical products, pharmaceutical forms and indications in accordance with the company strategy
Ensure regulatory product life cycle management in co-operation with European Regulatory teams and in accordance with company strategy
Identify synergies and implement worksharing initiatives between the three countries in order to increase regulatory efficiency across the region
Maintenance of current knowledge of relevant legislation, including initial drafts and final documents and communicate this information in a timely manner to the impacted departments
Establishment of a quality system within the RA department in order to ensure compliance and readiness for inspection
Ensure implementation and updating of SOPs and Working Instructions in accordance with national and European legislation and requirements
Maintenance of regulatory systems and databases
Contribute to the development and the implementation of the company strategic and operating plans, in close collaboration with the other departments
Secure preparation and maintenance of common Nordics packs where this is possible and in accordance with portfolio and launch plans

Qualifications, Experience, Knowledge and Skills Required:

o Qualifications:
Degree in life sciences/ pharmacy or equivalent qualification(s)

o Experiences:
A demonstrated track record of achievement, management and responsibility in Regulatory Affairs from the Pharma industry

o Knowledge:
European pharmaceutical legislation, relevant guidelines, procedures and requirements
Scandinavian Regulatory authorities
Scandinavian Pharmaceutical market dynamics

o Skills:
Fluency in English and Swedish, Norwegian or Danish
Excellent verbal communication skills
Ability to work under pressure and to tight timelines
Ability to organize, plan and prioritize work
Proven skills in leadership, problem solving and decision making
Strong capability to establish and maintain constructive interpersonal relationships
Good negotiation skills

Travelling
The position means frequent trips between Teva's offices in Sweden and Denmark.
Furthermore, a few trips a year to Teva's European and global headquarters.

Contact
For more information about the position as Regulatory Affairs Manager Scandinavia, please contact :
Magnus Klingberg, Recruitment Consultant, PeakSearch.
Tel: +46-(0)8-545 00 100, Mobile: +46- (0)70-678 09 92
magnus.klingberg@peaksearch.se

Catharina Herbertsson, Recruitment Consultant, PeakSearch.
Tel: +46 (0)706 152772
catharina.herbertsson@peaksearch.se

Eva Runnerström, Recruitment Consultant, PeakSearch.
Tel: +46 (0)701 725379
eva.runnerstrom@peaksearch.se

http://www.PeakSearch.se